Deeanna Franklin

Members of Disaster Psychiatry Outreach who traveled to Sri Lanka after the late December tsunami say their initial efforts to assist survivors are just the beginning.

“What we did was the easy part,” Craig Katz, M.D., cofounder and president of the New York-based DPO, told CLINICAL PSYCHIATRY NEWS. “What we saw and what we're going to do [about it] are the harder parts.”

Dr. Katz, who in January was accompanied by Nalaini Sriskandarajah, M.D., a DPO board member and child psychiatrist, said their objective was to develop a needs and assessment plan, and to determine how they could help.

The psychiatrists, who were hosted by local clubs, worked with the Rotary Council of Sri Lanka.

The devastation left by the tsunami that struck countries bordering the Indian Ocean on the morning of Dec. 26, 2004, is almost incomprehensible. Conservative estimates put the loss of life at 265,000-310,000, but a definitive count may be impossible.

The tsunami caused death and destruction in more than 11 countries, including Sri Lanka–where more than 31,000 people were killed, 12,000 of whom were children.

Nearly 1 million people in Sri Lanka were left homeless. The World Health Organization estimates that 90% of those displaced by the tsunami had also been displaced in the past because of more than 20 years of fighting between government forces and Tamil Tiger rebels.

Other countries affected were Indonesia, India, Thailand, Somalia, and South Africa. Centered off the western coast of north Sumatra, the undersea earthquake triggered waves up to 100 feet and will go down in history as the second largest ever recorded, at 9.3 on the seismograph.

While based in the city of Colombo, Dr. Katz and Dr. Sriskandarajah traveled through the affected southern districts of the country for several days. Then they visited northeast Sri Lanka, a region occupied by Tamil Tiger rebels. The regions are distinctly different.

“The reasons those distinctions are important is because [northern residents] are just emerging from years of war,” said Dr. Katz of the department of psychiatry at Mount Sinai School of Medicine, New York.

“They've had a truce there for about 2 years, and they were just climbing out of that and finally rebuilding economically and socially–and then [the tsunami] hit.”

While in the welfare camps, Dr. Katz said he remembers seeing a house that had been destroyed. Part of a wall was still standing and in it were bullet holes–apparently because the house was shot at during the war.

“It was a complete symbol of one bad thing happening on top of another,” Dr. Katz said. “That was rather powerful, and it was just a piece of concrete.”

In this part of the country, a group of about 18 counselors has been active since 1996. Their work during the conflict better prepared them to deal with this event, he said. They're not health professionals, but they've acquired a lot of training and experience over the years.

“We're hoping to work with them and give them some more specialized training … in child work and a little bit of [cognitive-behavioral therapy] to help them,” Dr. Katz said.

Whenever they could, he and Dr. Sriskandarajah visited “child-centered spaces,” which are designed to give children a place to play together.

Those spaces proved to be particularly important given the range of problems –including sleeplessness, nightmares, and flashbacks–that officials observed among the children at the newly established base hospitals in each district.

“In the daytime, they were happy and playing, because they were given structured activities,” Dr. Sriskandarajah said in an interview with this newspaper. “But they were waking up in the middle of the night or having nightmares, or refusing to go to sleep.”

The children sometimes have weekly visits from a psychiatrist who supervises the camp coordinators, which are the Sri Lankan equivalent of what we would call house officers, Dr. Katz said.

But resources are limited, and an on-site mental health staff is nonexistent.

Many children have been unable to sleep because they fear that the tsunami might return, one counselor told Dr. Sriskandarajah.

The counselors responded by lighting a fire outside. They told the children that if the fire went out, it would mean that the tsunami was returning–and the children could run.

“It seems to have helped the children a little bit,” said Dr. Sriskandarajah, who was born in Sri Lanka, is in private practice in Poughkeepsie, N.Y., and serves as chairwoman of the DPO's child and adolescent committee.

“These were [the] kinds of things that people were doing.”

She described a case of what she called tsunami hysteria. “While we were there, a little girl started yelling 'tsunami is coming; tsunami is coming.'

“Sure enough, on that day, there was another minor tremor. There was no tidal wave, but people got scared. The moral of the story is that through the hysteria they were expressing, the children got the whole camp riled up,” said Dr. Sriskandarajah, speaking prior to the 8.7 earthquake that hit the area March 28.

Tsunami survivors are best helped by other survivors, said Vijay Chandra, M.D., a World Health Organization regional mental health adviser.

“The best method of dealing with [the devastation] would be to find people in neighboring villages or communities, people of similar cultural background, who understand the cultural norms to help them,” Dr. Chandra said in a statement.

Additionally, the WHO is improving mental health services in Sri Lanka and has provided a 1-day refresher workshop on psychosocial approaches for 150 school advisers, who will work with teachers in tsunami-affected areas.

The WHO has encouraged aid workers in affected countries to implement the organization's document “Mental Health in Emergencies,” which emphasizes a culturally sensitive approach to care through increased community outreach efforts and by customizing support to meet the special needs of children, women, and the elderly.

The Rotary Clubs have asked Disaster Psychiatry Outreach to train lay counselors to help in affected communities, but Dr. Katz acknowledged that the prospect is overwhelming.

“It's much easier for us to train a bunch of psychiatrists on how to do disaster psychiatry–or train a bunch of physicians on how to identify PTSD [posttraumatic stress disorder],” he said.

Another possibility is to send psychiatrists over there to do direct care, which is how the DPO was originally envisioned: “as a kind of Doctors Without Borders for psychiatry.

” I don't think we've ruled that out for Sri Lanka, but it would require a lot of resources and funding that I'm not sure we'd have in place,” he said.

The organization plans to reach out to Sri Lankan expatriates in the North American psychiatric community a bit further, and Dr. Sriskandarajah also has contacts in the United Kingdom and in Australia.

“We want to send some child psychiatrists,” she said. “But child psychiatrists are in short supply here.”

In late March, the DPO led a team of four physicians to the Kilinochichi and Mullaitivu district on a 2-week mission to work with counselors in the Annai Illam counseling program. They will be trained in general disaster psychiatry, post-disaster child interventions, and cognitive-behavioral therapy for trauma-affected people. These were the same counselors who helped area residents recover psychologically from years of civil war.

And the DPO undertook another trip to Sri Lanka in late April–this time to the southern and western areas.

According to Dr. Katz, the DPO is committed to developing a sustainable program for Sri Lanka and not having its efforts turn into “2 weeks of disaster tourism and then it's over.”

Ultimately, the organization hopes to work with community groups and to train local leaders to be counselors within their communities.

“We can't make them psychiatrists overnight. But we can build up basic knowledge of mental health in these communities so that they can be peer counselors and use what we know is a crucial part of recovery from trauma: good psychosocial support,” Dr. Katz said. We want them to “somehow use their instincts of supporting each other and add a pinch of psychiatric expertise.

“That is what we are hoping to be able to do.”

If you'd like to participate in preparations for and/or direct missions to Sri Lanka, contact the DPO for more information at 212-598-9995 or visitwww.disasterpsych.org

Members of Disaster Psychiatry Outreach who traveled to Sri Lanka after the late December tsunami say their initial efforts to assist survivors are just the beginning.

“What we did was the easy part,” Craig Katz, M.D., cofounder and president of the New York-based DPO, told CLINICAL PSYCHIATRY NEWS. “What we saw and what we're going to do [about it] are the harder parts.”

Dr. Katz, who in January was accompanied by Nalaini Sriskandarajah, M.D., a DPO board member and child psychiatrist, said their objective was to develop a needs and assessment plan, and to determine how they could help.

The psychiatrists, who were hosted by local clubs, worked with the Rotary Council of Sri Lanka.

The devastation left by the tsunami that struck countries bordering the Indian Ocean on the morning of Dec. 26, 2004, is almost incomprehensible. Conservative estimates put the loss of life at 265,000-310,000, but a definitive count may be impossible.

The tsunami caused death and destruction in more than 11 countries, including Sri Lanka–where more than 31,000 people were killed, 12,000 of whom were children.

Nearly 1 million people in Sri Lanka were left homeless. The World Health Organization estimates that 90% of those displaced by the tsunami had also been displaced in the past because of more than 20 years of fighting between government forces and Tamil Tiger rebels.

Other countries affected were Indonesia, India, Thailand, Somalia, and South Africa. Centered off the western coast of north Sumatra, the undersea earthquake triggered waves up to 100 feet and will go down in history as the second largest ever recorded, at 9.3 on the seismograph.

While based in the city of Colombo, Dr. Katz and Dr. Sriskandarajah traveled through the affected southern districts of the country for several days. Then they visited northeast Sri Lanka, a region occupied by Tamil Tiger rebels. The regions are distinctly different.

“The reasons those distinctions are important is because [northern residents] are just emerging from years of war,” said Dr. Katz of the department of psychiatry at Mount Sinai School of Medicine, New York.

“They've had a truce there for about 2 years, and they were just climbing out of that and finally rebuilding economically and socially–and then [the tsunami] hit.”

While in the welfare camps, Dr. Katz said he remembers seeing a house that had been destroyed. Part of a wall was still standing and in it were bullet holes–apparently because the house was shot at during the war.

“It was a complete symbol of one bad thing happening on top of another,” Dr. Katz said. “That was rather powerful, and it was just a piece of concrete.”

In this part of the country, a group of about 18 counselors has been active since 1996. Their work during the conflict better prepared them to deal with this event, he said. They're not health professionals, but they've acquired a lot of training and experience over the years.

“We're hoping to work with them and give them some more specialized training … in child work and a little bit of [cognitive-behavioral therapy] to help them,” Dr. Katz said.

Whenever they could, he and Dr. Sriskandarajah visited “child-centered spaces,” which are designed to give children a place to play together.

Those spaces proved to be particularly important given the range of problems –including sleeplessness, nightmares, and flashbacks–that officials observed among the children at the newly established base hospitals in each district.

“In the daytime, they were happy and playing, because they were given structured activities,” Dr. Sriskandarajah said in an interview with this newspaper. “But they were waking up in the middle of the night or having nightmares, or refusing to go to sleep.”

The children sometimes have weekly visits from a psychiatrist who supervises the camp coordinators, which are the Sri Lankan equivalent of what we would call house officers, Dr. Katz said.

But resources are limited, and an on-site mental health staff is nonexistent.

Many children have been unable to sleep because they fear that the tsunami might return, one counselor told Dr. Sriskandarajah.

The counselors responded by lighting a fire outside. They told the children that if the fire went out, it would mean that the tsunami was returning–and the children could run.

“It seems to have helped the children a little bit,” said Dr. Sriskandarajah, who was born in Sri Lanka, is in private practice in Poughkeepsie, N.Y., and serves as chairwoman of the DPO's child and adolescent committee.

“These were [the] kinds of things that people were doing.”

She described a case of what she called tsunami hysteria. “While we were there, a little girl started yelling 'tsunami is coming; tsunami is coming.'

“Sure enough, on that day, there was another minor tremor. There was no tidal wave, but people got scared. The moral of the story is that through the hysteria they were expressing, the children got the whole camp riled up,” said Dr. Sriskandarajah, speaking prior to the 8.7 earthquake that hit the area March 28.

Tsunami survivors are best helped by other survivors, said Vijay Chandra, M.D., a World Health Organization regional mental health adviser.

“The best method of dealing with [the devastation] would be to find people in neighboring villages or communities, people of similar cultural background, who understand the cultural norms to help them,” Dr. Chandra said in a statement.

Additionally, the WHO is improving mental health services in Sri Lanka and has provided a 1-day refresher workshop on psychosocial approaches for 150 school advisers, who will work with teachers in tsunami-affected areas.

The WHO has encouraged aid workers in affected countries to implement the organization's document “Mental Health in Emergencies,” which emphasizes a culturally sensitive approach to care through increased community outreach efforts and by customizing support to meet the special needs of children, women, and the elderly.

The Rotary Clubs have asked Disaster Psychiatry Outreach to train lay counselors to help in affected communities, but Dr. Katz acknowledged that the prospect is overwhelming.

“It's much easier for us to train a bunch of psychiatrists on how to do disaster psychiatry–or train a bunch of physicians on how to identify PTSD [posttraumatic stress disorder],” he said.

Another possibility is to send psychiatrists over there to do direct care, which is how the DPO was originally envisioned: “as a kind of Doctors Without Borders for psychiatry.

” I don't think we've ruled that out for Sri Lanka, but it would require a lot of resources and funding that I'm not sure we'd have in place,” he said.

The organization plans to reach out to Sri Lankan expatriates in the North American psychiatric community a bit further, and Dr. Sriskandarajah also has contacts in the United Kingdom and in Australia.

“We want to send some child psychiatrists,” she said. “But child psychiatrists are in short supply here.”

In late March, the DPO led a team of four physicians to the Kilinochichi and Mullaitivu district on a 2-week mission to work with counselors in the Annai Illam counseling program. They will be trained in general disaster psychiatry, post-disaster child interventions, and cognitive-behavioral therapy for trauma-affected people. These were the same counselors who helped area residents recover psychologically from years of civil war.

And the DPO undertook another trip to Sri Lanka in late April–this time to the southern and western areas.

According to Dr. Katz, the DPO is committed to developing a sustainable program for Sri Lanka and not having its efforts turn into “2 weeks of disaster tourism and then it's over.”

Ultimately, the organization hopes to work with community groups and to train local leaders to be counselors within their communities.

“We can't make them psychiatrists overnight. But we can build up basic knowledge of mental health in these communities so that they can be peer counselors and use what we know is a crucial part of recovery from trauma: good psychosocial support,” Dr. Katz said. We want them to “somehow use their instincts of supporting each other and add a pinch of psychiatric expertise.

“That is what we are hoping to be able to do.”

If you'd like to participate in preparations for and/or direct missions to Sri Lanka, contact the DPO for more information at 212-598-9995 or visitwww.disasterpsych.org

Members of Disaster Psychiatry Outreach who traveled to Sri Lanka after the late December tsunami say their initial efforts to assist survivors are just the beginning.

“What we did was the easy part,” Craig Katz, M.D., cofounder and president of the New York-based DPO, told CLINICAL PSYCHIATRY NEWS. “What we saw and what we're going to do [about it] are the harder parts.”

Dr. Katz, who in January was accompanied by Nalaini Sriskandarajah, M.D., a DPO board member and child psychiatrist, said their objective was to develop a needs and assessment plan, and to determine how they could help.

The psychiatrists, who were hosted by local clubs, worked with the Rotary Council of Sri Lanka.

The devastation left by the tsunami that struck countries bordering the Indian Ocean on the morning of Dec. 26, 2004, is almost incomprehensible. Conservative estimates put the loss of life at 265,000-310,000, but a definitive count may be impossible.

The tsunami caused death and destruction in more than 11 countries, including Sri Lanka–where more than 31,000 people were killed, 12,000 of whom were children.

Nearly 1 million people in Sri Lanka were left homeless. The World Health Organization estimates that 90% of those displaced by the tsunami had also been displaced in the past because of more than 20 years of fighting between government forces and Tamil Tiger rebels.

Other countries affected were Indonesia, India, Thailand, Somalia, and South Africa. Centered off the western coast of north Sumatra, the undersea earthquake triggered waves up to 100 feet and will go down in history as the second largest ever recorded, at 9.3 on the seismograph.

While based in the city of Colombo, Dr. Katz and Dr. Sriskandarajah traveled through the affected southern districts of the country for several days. Then they visited northeast Sri Lanka, a region occupied by Tamil Tiger rebels. The regions are distinctly different.

“The reasons those distinctions are important is because [northern residents] are just emerging from years of war,” said Dr. Katz of the department of psychiatry at Mount Sinai School of Medicine, New York.

“They've had a truce there for about 2 years, and they were just climbing out of that and finally rebuilding economically and socially–and then [the tsunami] hit.”

While in the welfare camps, Dr. Katz said he remembers seeing a house that had been destroyed. Part of a wall was still standing and in it were bullet holes–apparently because the house was shot at during the war.

“It was a complete symbol of one bad thing happening on top of another,” Dr. Katz said. “That was rather powerful, and it was just a piece of concrete.”

In this part of the country, a group of about 18 counselors has been active since 1996. Their work during the conflict better prepared them to deal with this event, he said. They're not health professionals, but they've acquired a lot of training and experience over the years.

“We're hoping to work with them and give them some more specialized training … in child work and a little bit of [cognitive-behavioral therapy] to help them,” Dr. Katz said.

Whenever they could, he and Dr. Sriskandarajah visited “child-centered spaces,” which are designed to give children a place to play together.

Those spaces proved to be particularly important given the range of problems –including sleeplessness, nightmares, and flashbacks–that officials observed among the children at the newly established base hospitals in each district.

“In the daytime, they were happy and playing, because they were given structured activities,” Dr. Sriskandarajah said in an interview with this newspaper. “But they were waking up in the middle of the night or having nightmares, or refusing to go to sleep.”

The children sometimes have weekly visits from a psychiatrist who supervises the camp coordinators, which are the Sri Lankan equivalent of what we would call house officers, Dr. Katz said.

But resources are limited, and an on-site mental health staff is nonexistent.

Many children have been unable to sleep because they fear that the tsunami might return, one counselor told Dr. Sriskandarajah.

The counselors responded by lighting a fire outside. They told the children that if the fire went out, it would mean that the tsunami was returning–and the children could run.

“It seems to have helped the children a little bit,” said Dr. Sriskandarajah, who was born in Sri Lanka, is in private practice in Poughkeepsie, N.Y., and serves as chairwoman of the DPO's child and adolescent committee.

“These were [the] kinds of things that people were doing.”

She described a case of what she called tsunami hysteria. “While we were there, a little girl started yelling 'tsunami is coming; tsunami is coming.'

“Sure enough, on that day, there was another minor tremor. There was no tidal wave, but people got scared. The moral of the story is that through the hysteria they were expressing, the children got the whole camp riled up,” said Dr. Sriskandarajah, speaking prior to the 8.7 earthquake that hit the area March 28.

Tsunami survivors are best helped by other survivors, said Vijay Chandra, M.D., a World Health Organization regional mental health adviser.

“The best method of dealing with [the devastation] would be to find people in neighboring villages or communities, people of similar cultural background, who understand the cultural norms to help them,” Dr. Chandra said in a statement.

Additionally, the WHO is improving mental health services in Sri Lanka and has provided a 1-day refresher workshop on psychosocial approaches for 150 school advisers, who will work with teachers in tsunami-affected areas.

The WHO has encouraged aid workers in affected countries to implement the organization's document “Mental Health in Emergencies,” which emphasizes a culturally sensitive approach to care through increased community outreach efforts and by customizing support to meet the special needs of children, women, and the elderly.

The Rotary Clubs have asked Disaster Psychiatry Outreach to train lay counselors to help in affected communities, but Dr. Katz acknowledged that the prospect is overwhelming.

“It's much easier for us to train a bunch of psychiatrists on how to do disaster psychiatry–or train a bunch of physicians on how to identify PTSD [posttraumatic stress disorder],” he said.

Another possibility is to send psychiatrists over there to do direct care, which is how the DPO was originally envisioned: “as a kind of Doctors Without Borders for psychiatry.

” I don't think we've ruled that out for Sri Lanka, but it would require a lot of resources and funding that I'm not sure we'd have in place,” he said.

The organization plans to reach out to Sri Lankan expatriates in the North American psychiatric community a bit further, and Dr. Sriskandarajah also has contacts in the United Kingdom and in Australia.

“We want to send some child psychiatrists,” she said. “But child psychiatrists are in short supply here.”

In late March, the DPO led a team of four physicians to the Kilinochichi and Mullaitivu district on a 2-week mission to work with counselors in the Annai Illam counseling program. They will be trained in general disaster psychiatry, post-disaster child interventions, and cognitive-behavioral therapy for trauma-affected people. These were the same counselors who helped area residents recover psychologically from years of civil war.

And the DPO undertook another trip to Sri Lanka in late April–this time to the southern and western areas.

According to Dr. Katz, the DPO is committed to developing a sustainable program for Sri Lanka and not having its efforts turn into “2 weeks of disaster tourism and then it's over.”

Ultimately, the organization hopes to work with community groups and to train local leaders to be counselors within their communities.

“We can't make them psychiatrists overnight. But we can build up basic knowledge of mental health in these communities so that they can be peer counselors and use what we know is a crucial part of recovery from trauma: good psychosocial support,” Dr. Katz said. We want them to “somehow use their instincts of supporting each other and add a pinch of psychiatric expertise.

“That is what we are hoping to be able to do.”

If you'd like to participate in preparations for and/or direct missions to Sri Lanka, contact the DPO for more information at 212-598-9995 or visitwww.disasterpsych.org

BOSTON — A few adjustments might be needed to make your practice approachable and comfortable for adolescent patients, but the long-term payoffs can be worth it.

“Why is it some people aren't so comfortable taking care of adolescents? They think they take more time in the office. They have varied issues. It's sometimes challenging, and a lot of ob.gyn. residency programs didn't address pediatric or adolescent gynecology specifically,” Marc Laufer, M.D., said at an ob.gyn. meeting sponsored by Harvard Medical School.

“We're aware of that, and we're trying to address it through the American College of Obstetricians and Gynecologists and the North American Society for Pediatric and Adolescent Gynecology [NASPAG],” said Dr. Laufer of Harvard and chief of gynecology at Children's Hospital Boston.

Confidentiality is “one of the key issues” in making a practice more friendly for adolescents. One critical move is to make sure sound doesn't carry. If office walls aren't soundproof, Dr. Laufer suggested using sound machines, such as white noise machines or sound conditioners, which can help mask sounds between offices.

When it comes to certain diseases, “if we treat and diagnose them when people are younger, we may improve their long-term health care,” Dr. Laufer said at the meeting cosponsored by Brigham and Women's Hospital.

For example, if polycystic ovary syndrome were diagnosed and treated during adolescence, there would be a greater chance of decreasing rates of obesity and diabetes, said Dr. Laufer. The same holds for endometriosis. An early diagnosis likely would result in less pelvic pain over the patient's lifetime and lead to improved long-term fertility.

Since most adolescents are “Internet savvy,” Dr. Laufer encouraged physicians to direct young patients to online resources such as the Center for Young Women's Health at Children's Hospital Boston (www.youngwomenshealth.org

The NASPAG's Web site (www.naspag.org

BOSTON — A few adjustments might be needed to make your practice approachable and comfortable for adolescent patients, but the long-term payoffs can be worth it.

“Why is it some people aren't so comfortable taking care of adolescents? They think they take more time in the office. They have varied issues. It's sometimes challenging, and a lot of ob.gyn. residency programs didn't address pediatric or adolescent gynecology specifically,” Marc Laufer, M.D., said at an ob.gyn. meeting sponsored by Harvard Medical School.

“We're aware of that, and we're trying to address it through the American College of Obstetricians and Gynecologists and the North American Society for Pediatric and Adolescent Gynecology [NASPAG],” said Dr. Laufer of Harvard and chief of gynecology at Children's Hospital Boston.

Confidentiality is “one of the key issues” in making a practice more friendly for adolescents. One critical move is to make sure sound doesn't carry. If office walls aren't soundproof, Dr. Laufer suggested using sound machines, such as white noise machines or sound conditioners, which can help mask sounds between offices.

When it comes to certain diseases, “if we treat and diagnose them when people are younger, we may improve their long-term health care,” Dr. Laufer said at the meeting cosponsored by Brigham and Women's Hospital.

For example, if polycystic ovary syndrome were diagnosed and treated during adolescence, there would be a greater chance of decreasing rates of obesity and diabetes, said Dr. Laufer. The same holds for endometriosis. An early diagnosis likely would result in less pelvic pain over the patient's lifetime and lead to improved long-term fertility.

Since most adolescents are “Internet savvy,” Dr. Laufer encouraged physicians to direct young patients to online resources such as the Center for Young Women's Health at Children's Hospital Boston (www.youngwomenshealth.org

The NASPAG's Web site (www.naspag.org

BOSTON — A few adjustments might be needed to make your practice approachable and comfortable for adolescent patients, but the long-term payoffs can be worth it.

“Why is it some people aren't so comfortable taking care of adolescents? They think they take more time in the office. They have varied issues. It's sometimes challenging, and a lot of ob.gyn. residency programs didn't address pediatric or adolescent gynecology specifically,” Marc Laufer, M.D., said at an ob.gyn. meeting sponsored by Harvard Medical School.

“We're aware of that, and we're trying to address it through the American College of Obstetricians and Gynecologists and the North American Society for Pediatric and Adolescent Gynecology [NASPAG],” said Dr. Laufer of Harvard and chief of gynecology at Children's Hospital Boston.

Confidentiality is “one of the key issues” in making a practice more friendly for adolescents. One critical move is to make sure sound doesn't carry. If office walls aren't soundproof, Dr. Laufer suggested using sound machines, such as white noise machines or sound conditioners, which can help mask sounds between offices.

When it comes to certain diseases, “if we treat and diagnose them when people are younger, we may improve their long-term health care,” Dr. Laufer said at the meeting cosponsored by Brigham and Women's Hospital.

For example, if polycystic ovary syndrome were diagnosed and treated during adolescence, there would be a greater chance of decreasing rates of obesity and diabetes, said Dr. Laufer. The same holds for endometriosis. An early diagnosis likely would result in less pelvic pain over the patient's lifetime and lead to improved long-term fertility.

Since most adolescents are “Internet savvy,” Dr. Laufer encouraged physicians to direct young patients to online resources such as the Center for Young Women's Health at Children's Hospital Boston (www.youngwomenshealth.org

The NASPAG's Web site (www.naspag.org

BALTIMORE — When it comes to the perceived stigma associated with mental illness, age and gender differences exist, and this stigma continues to pose a significant barrier to care, reported Jo Anne Sirey, Ph.D., and Martha L. Bruce, Ph.D., of Cornell University, White Plains, N.Y.

They studied 125 older adults (aged 64 years and older) and 103 younger adults (aged 18-64 years) with DSM-IV major depressive disorder. Education levels and gender distributions were similar for both groups. Older adults were more likely than younger adults to believe that most people would accept that someone with mental illness was as intelligent (59% vs. 40%) and trustworthy (40% vs. 22%) as the average person, the researchers said in a poster presentation at the annual meeting of the American Association for Geriatric Psychiatry.

Also, a majority in each group perceived a high degree of discrimination and devaluation as a result of mental illness and believed this extended to the acceptance of individuals in various roles, such as teacher, job applicant, or suitor. Younger adults perceived an even higher level of stigma, compared with older adults, with young women reporting the highest levels of perceived stigma. Degree of perceived stigma was unrelated to depression severity.

“Individualized inquiry sensitive to age and gender stigma concerns can uncover potential barriers to care,” they concluded.

BALTIMORE — When it comes to the perceived stigma associated with mental illness, age and gender differences exist, and this stigma continues to pose a significant barrier to care, reported Jo Anne Sirey, Ph.D., and Martha L. Bruce, Ph.D., of Cornell University, White Plains, N.Y.

They studied 125 older adults (aged 64 years and older) and 103 younger adults (aged 18-64 years) with DSM-IV major depressive disorder. Education levels and gender distributions were similar for both groups. Older adults were more likely than younger adults to believe that most people would accept that someone with mental illness was as intelligent (59% vs. 40%) and trustworthy (40% vs. 22%) as the average person, the researchers said in a poster presentation at the annual meeting of the American Association for Geriatric Psychiatry.

Also, a majority in each group perceived a high degree of discrimination and devaluation as a result of mental illness and believed this extended to the acceptance of individuals in various roles, such as teacher, job applicant, or suitor. Younger adults perceived an even higher level of stigma, compared with older adults, with young women reporting the highest levels of perceived stigma. Degree of perceived stigma was unrelated to depression severity.

“Individualized inquiry sensitive to age and gender stigma concerns can uncover potential barriers to care,” they concluded.

BALTIMORE — When it comes to the perceived stigma associated with mental illness, age and gender differences exist, and this stigma continues to pose a significant barrier to care, reported Jo Anne Sirey, Ph.D., and Martha L. Bruce, Ph.D., of Cornell University, White Plains, N.Y.

They studied 125 older adults (aged 64 years and older) and 103 younger adults (aged 18-64 years) with DSM-IV major depressive disorder. Education levels and gender distributions were similar for both groups. Older adults were more likely than younger adults to believe that most people would accept that someone with mental illness was as intelligent (59% vs. 40%) and trustworthy (40% vs. 22%) as the average person, the researchers said in a poster presentation at the annual meeting of the American Association for Geriatric Psychiatry.

Also, a majority in each group perceived a high degree of discrimination and devaluation as a result of mental illness and believed this extended to the acceptance of individuals in various roles, such as teacher, job applicant, or suitor. Younger adults perceived an even higher level of stigma, compared with older adults, with young women reporting the highest levels of perceived stigma. Degree of perceived stigma was unrelated to depression severity.

“Individualized inquiry sensitive to age and gender stigma concerns can uncover potential barriers to care,” they concluded.

WASHINGTON — Patients who received emergent cerclage had higher rates of premature birth, spontaneous premature rupture of membranes, and chorioamnionitis, compared with those receiving elective cerclages, Chi P. Dola, M.D., reported in a poster presentation at the annual meeting of District VII of the American College of Obstetricians and Gynecologists.

Dr. Dola, of Tulane University, New Orleans, and her colleagues performed a retrospective chart review of data from 140 pregnant women who presented with an incompetent cervix.

The women were separated into three groups: 91 asymptomatic patients who received an elective cerclage based on a history suggestive of cervical incompetence; 29 asymptomatic patients who received an urgent cerclage after an ultrasound exam brought to light an abnormal finding, and 20 patients who received an emergent cerclage after presenting with typical symptoms of cervical incompetence.

The percentage of patients whose pregnancy lasted beyond 36 weeks was the highest, at 73%, in those who received an elective cerclage, followed by 62% in the asymptomatic patients who received urgent cerclage and 21% in the symptomatic patients who had an urgent cerclage.

Spontaneous premature rupture of membranes was 21% in the asymptomatic patients who received elective cerclage, versus 40% and 71% in the other two groups, respectively.

The incidence of chorioamnionitis was only 2% in the asymptomatic patients who received elective cerclage, compared with 9% and 50% in the other two groups, respectively.

All differences between groups were significant.

The researchers' findings show that patients with urgent cerclages had poor outcomes compared with those receiving elective cerclages. This finding led the researchers to conclude “that by awaiting abnormal cervical findings on ultrasound exam prior to placement of an urgent cerclage, the potential for poor pregnancy outcomes increases.”

WASHINGTON — Patients who received emergent cerclage had higher rates of premature birth, spontaneous premature rupture of membranes, and chorioamnionitis, compared with those receiving elective cerclages, Chi P. Dola, M.D., reported in a poster presentation at the annual meeting of District VII of the American College of Obstetricians and Gynecologists.

Dr. Dola, of Tulane University, New Orleans, and her colleagues performed a retrospective chart review of data from 140 pregnant women who presented with an incompetent cervix.

The women were separated into three groups: 91 asymptomatic patients who received an elective cerclage based on a history suggestive of cervical incompetence; 29 asymptomatic patients who received an urgent cerclage after an ultrasound exam brought to light an abnormal finding, and 20 patients who received an emergent cerclage after presenting with typical symptoms of cervical incompetence.

The percentage of patients whose pregnancy lasted beyond 36 weeks was the highest, at 73%, in those who received an elective cerclage, followed by 62% in the asymptomatic patients who received urgent cerclage and 21% in the symptomatic patients who had an urgent cerclage.

Spontaneous premature rupture of membranes was 21% in the asymptomatic patients who received elective cerclage, versus 40% and 71% in the other two groups, respectively.

The incidence of chorioamnionitis was only 2% in the asymptomatic patients who received elective cerclage, compared with 9% and 50% in the other two groups, respectively.

All differences between groups were significant.

The researchers' findings show that patients with urgent cerclages had poor outcomes compared with those receiving elective cerclages. This finding led the researchers to conclude “that by awaiting abnormal cervical findings on ultrasound exam prior to placement of an urgent cerclage, the potential for poor pregnancy outcomes increases.”

WASHINGTON — Patients who received emergent cerclage had higher rates of premature birth, spontaneous premature rupture of membranes, and chorioamnionitis, compared with those receiving elective cerclages, Chi P. Dola, M.D., reported in a poster presentation at the annual meeting of District VII of the American College of Obstetricians and Gynecologists.

Dr. Dola, of Tulane University, New Orleans, and her colleagues performed a retrospective chart review of data from 140 pregnant women who presented with an incompetent cervix.

The women were separated into three groups: 91 asymptomatic patients who received an elective cerclage based on a history suggestive of cervical incompetence; 29 asymptomatic patients who received an urgent cerclage after an ultrasound exam brought to light an abnormal finding, and 20 patients who received an emergent cerclage after presenting with typical symptoms of cervical incompetence.

The percentage of patients whose pregnancy lasted beyond 36 weeks was the highest, at 73%, in those who received an elective cerclage, followed by 62% in the asymptomatic patients who received urgent cerclage and 21% in the symptomatic patients who had an urgent cerclage.

Spontaneous premature rupture of membranes was 21% in the asymptomatic patients who received elective cerclage, versus 40% and 71% in the other two groups, respectively.

The incidence of chorioamnionitis was only 2% in the asymptomatic patients who received elective cerclage, compared with 9% and 50% in the other two groups, respectively.

All differences between groups were significant.

The researchers' findings show that patients with urgent cerclages had poor outcomes compared with those receiving elective cerclages. This finding led the researchers to conclude “that by awaiting abnormal cervical findings on ultrasound exam prior to placement of an urgent cerclage, the potential for poor pregnancy outcomes increases.”

ROCKVILLE, MD. — Panelists on the Food and Drug Administration's Pediatric Advisory Committee strongly urged the FDA to overhaul MedWatch, its voluntary safety information and adverse event reporting program, to make the system less onerous.

Currently, the program entails the submission of a five-page report, and the submission often triggers a follow-up interview via telephone.

“Consider the possibility of streamlining the adverse event reporting system so that people don't mind doing it,” advised Thomas Newman, M.D., of the University of California, San Francisco.

“Create a system that is more specific and less open to interpretation, so that way the data would be stronger and potentially cleaner,” recommended another panel member.

Panelists suggested making the system more user friendly, in addition to having narrative descriptions that are more consistent across categories.

For example, one provider may use a description of “loose stool” while another would use the term “diarrhea.”

“I feel like I'm not serving the general public or the government of the United States, with the current information that I'm receiving. I am not capable of being assured in any way about safety with the [current] passive surveillance system. We have to get better information,” said Mary Glode, M.D., an infectious diseases specialist with the University of Colorado, Denver.

FDA representatives acknowledged that underreporting of adverse events and establishing causality are ongoing challenges under the current MedWatch system.

“There's a lot of missing information. We try to make the most out of this limited information. It's a good system to pick up some rare, serious events,” said an FDA representative.

The panelists also heard data compiled as part of the 1-year postexclusivity adverse event review program mandated by the Best Pharmaceuticals for Children Act.

Information was presented on the following medications:

Benazepril (Lotensin, Lotensin HCT, Lotrel).

▸ Approved: June 25, 1991, manufactured by Novartis.

▸ Indication: This antihypertensive (ACE inhibitor) is used to treat hypertension in patients over 6 years of age.

▸ Pediatric Adverse Events Reported: Three adverse events (AEs) in 1-year period reviewed, and five total since its approval; all were serious, none were fatal. No patterns discernible in the AEs for benazepril monotherapy. No AEs reported for benazepril's combination products.

▸ FDA Recommendation: Return to routine monitoring. The agency recommended routine monitoring of AEs, focusing on serious AEs in all populations, as opposed to giving special attention to all pediatric AEs reported as mandated by the 1-year exclusivity period.

▸ Panel Recommendation: The panel did not concur, and regarded the data presented as too inadequate for a return to routine monitoring. They recommended the FDA “look closely at all case reports for benazepril for yet another year and then report back to the committee,” said panel chair, P. Joan Chesney, M.D., an infectious diseases specialist and director of academic programs at St. Jude Children's Research Hospital, Memphis.

Esmolol (Brevibloc).

▸ Approved: December 31, 1986, manufactured by Baxter Laboratories.

▸ Indication: No pediatric indication. In adults, this β-1-selective (cardioselective) adrenergic receptor blocking agent is used to treat supraventricular tachycardia, intraoperative and postoperative tachycardia and/or hypertension.

▸ Pediatric Adverse Events Reported: During the 1-year postexclusivity period there was one pediatric AE reported. Since its approval there were 13 pediatric AEs reported (9 serious, 3 deaths). No discernible patterns in AEs.

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel did not concur, and regarded the data presented as insufficient. Recommended another year-long exclusivity period.

Orlistat (Xenical).

▸ Approved: April 23, 1999, manufactured by Roche.

▸ Indication: A lipase inhibitor for obesity management in conjunction with weight loss in patients aged 12 years and older with a body mass index greater than 30, or 27 with risk factors (hypertension, diabetes, dyslipidemia). Less than 1% (about 4,000) annual prescriptions for the drug were for pediatric patients.

▸ Pediatric Adverse Events Reported: Twenty-two pediatric AEs were reported (21 serious, no deaths). There was one serious AE reported during the 1-year postexclusivity period.

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel concurred.

Glyburide-Metformin (Glucovance).

▸ Approved: July 31, 2000, manufactured by Bristol-Myers Squibb Co.

▸ Indication: An antihyperglycemic for the adjunct treatment of type 2 diabetes mellitus along with diet and exercise, as well as a second-line treatment for type 2 diabetes if metformin or sulfonylurea fail. The glyburide stimulates release of insulin while the metformin improves glucose tolerance.

▸ Pediatric Adverse Events Reported: No AE reports in this population since Glucovance's approval. Both drugs have minimal use in pediatric patients.

▸ FDA Recommendation: Return to routine monitoring for the drug combo.

▸ Panel Recommendation: The panel concurred.

Atovaquone-Proguanil (Malarone Pediatric).

▸ Approved: July 14, 2000, manufactured by GlaxoSmithKline

▸ Indication: An antimalarial used in the treatment of Plasmodium falciparum malaria in patients over 5 kg and prophylaxis in patients over 1 kg.

▸ Pediatric Adverse Events Reported: Seven AEs were reported during the 1-year postexclusivity period (six serious, no deaths). There were 17 AEs reported since the drug's approval (15 serious, 3 deaths).

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel unanimously concurred.

Nelfinavir Mesylate (Viracept).

▸ Approved: March 14, 1997, manufactured by Pfizer Inc.

▸ Indication: A protease inhibitor indicated for the treatment of HIV infection in patients over 2 years of age. Accounted for about 16.4% of the 1.9 million prescriptions dispensed in this drug class from Sept. 2003 to Aug. 2004.

▸ Pediatric Adverse Events Reported: There were 377 AEs reported since the drug's approval (374 serious, 19 deaths). During the 1-year postexclusivity period, there were 30 AEs reported (30 serious, 2 deaths).

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel agreed.n

ROCKVILLE, MD. — Panelists on the Food and Drug Administration's Pediatric Advisory Committee strongly urged the FDA to overhaul MedWatch, its voluntary safety information and adverse event reporting program, to make the system less onerous.

Currently, the program entails the submission of a five-page report, and the submission often triggers a follow-up interview via telephone.

“Consider the possibility of streamlining the adverse event reporting system so that people don't mind doing it,” advised Thomas Newman, M.D., of the University of California, San Francisco.

“Create a system that is more specific and less open to interpretation, so that way the data would be stronger and potentially cleaner,” recommended another panel member.

Panelists suggested making the system more user friendly, in addition to having narrative descriptions that are more consistent across categories.

For example, one provider may use a description of “loose stool” while another would use the term “diarrhea.”

“I feel like I'm not serving the general public or the government of the United States, with the current information that I'm receiving. I am not capable of being assured in any way about safety with the [current] passive surveillance system. We have to get better information,” said Mary Glode, M.D., an infectious diseases specialist with the University of Colorado, Denver.

FDA representatives acknowledged that underreporting of adverse events and establishing causality are ongoing challenges under the current MedWatch system.

“There's a lot of missing information. We try to make the most out of this limited information. It's a good system to pick up some rare, serious events,” said an FDA representative.

The panelists also heard data compiled as part of the 1-year postexclusivity adverse event review program mandated by the Best Pharmaceuticals for Children Act.

Information was presented on the following medications:

Benazepril (Lotensin, Lotensin HCT, Lotrel).

▸ Approved: June 25, 1991, manufactured by Novartis.

▸ Indication: This antihypertensive (ACE inhibitor) is used to treat hypertension in patients over 6 years of age.

▸ Pediatric Adverse Events Reported: Three adverse events (AEs) in 1-year period reviewed, and five total since its approval; all were serious, none were fatal. No patterns discernible in the AEs for benazepril monotherapy. No AEs reported for benazepril's combination products.

▸ FDA Recommendation: Return to routine monitoring. The agency recommended routine monitoring of AEs, focusing on serious AEs in all populations, as opposed to giving special attention to all pediatric AEs reported as mandated by the 1-year exclusivity period.

▸ Panel Recommendation: The panel did not concur, and regarded the data presented as too inadequate for a return to routine monitoring. They recommended the FDA “look closely at all case reports for benazepril for yet another year and then report back to the committee,” said panel chair, P. Joan Chesney, M.D., an infectious diseases specialist and director of academic programs at St. Jude Children's Research Hospital, Memphis.

Esmolol (Brevibloc).

▸ Approved: December 31, 1986, manufactured by Baxter Laboratories.

▸ Indication: No pediatric indication. In adults, this β-1-selective (cardioselective) adrenergic receptor blocking agent is used to treat supraventricular tachycardia, intraoperative and postoperative tachycardia and/or hypertension.

▸ Pediatric Adverse Events Reported: During the 1-year postexclusivity period there was one pediatric AE reported. Since its approval there were 13 pediatric AEs reported (9 serious, 3 deaths). No discernible patterns in AEs.

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel did not concur, and regarded the data presented as insufficient. Recommended another year-long exclusivity period.

Orlistat (Xenical).

▸ Approved: April 23, 1999, manufactured by Roche.

▸ Indication: A lipase inhibitor for obesity management in conjunction with weight loss in patients aged 12 years and older with a body mass index greater than 30, or 27 with risk factors (hypertension, diabetes, dyslipidemia). Less than 1% (about 4,000) annual prescriptions for the drug were for pediatric patients.

▸ Pediatric Adverse Events Reported: Twenty-two pediatric AEs were reported (21 serious, no deaths). There was one serious AE reported during the 1-year postexclusivity period.

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel concurred.

Glyburide-Metformin (Glucovance).

▸ Approved: July 31, 2000, manufactured by Bristol-Myers Squibb Co.

▸ Indication: An antihyperglycemic for the adjunct treatment of type 2 diabetes mellitus along with diet and exercise, as well as a second-line treatment for type 2 diabetes if metformin or sulfonylurea fail. The glyburide stimulates release of insulin while the metformin improves glucose tolerance.

▸ Pediatric Adverse Events Reported: No AE reports in this population since Glucovance's approval. Both drugs have minimal use in pediatric patients.

▸ FDA Recommendation: Return to routine monitoring for the drug combo.

▸ Panel Recommendation: The panel concurred.

Atovaquone-Proguanil (Malarone Pediatric).

▸ Approved: July 14, 2000, manufactured by GlaxoSmithKline

▸ Indication: An antimalarial used in the treatment of Plasmodium falciparum malaria in patients over 5 kg and prophylaxis in patients over 1 kg.

▸ Pediatric Adverse Events Reported: Seven AEs were reported during the 1-year postexclusivity period (six serious, no deaths). There were 17 AEs reported since the drug's approval (15 serious, 3 deaths).

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel unanimously concurred.

Nelfinavir Mesylate (Viracept).

▸ Approved: March 14, 1997, manufactured by Pfizer Inc.

▸ Indication: A protease inhibitor indicated for the treatment of HIV infection in patients over 2 years of age. Accounted for about 16.4% of the 1.9 million prescriptions dispensed in this drug class from Sept. 2003 to Aug. 2004.

▸ Pediatric Adverse Events Reported: There were 377 AEs reported since the drug's approval (374 serious, 19 deaths). During the 1-year postexclusivity period, there were 30 AEs reported (30 serious, 2 deaths).

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel agreed.n

ROCKVILLE, MD. — Panelists on the Food and Drug Administration's Pediatric Advisory Committee strongly urged the FDA to overhaul MedWatch, its voluntary safety information and adverse event reporting program, to make the system less onerous.

Currently, the program entails the submission of a five-page report, and the submission often triggers a follow-up interview via telephone.

“Consider the possibility of streamlining the adverse event reporting system so that people don't mind doing it,” advised Thomas Newman, M.D., of the University of California, San Francisco.

“Create a system that is more specific and less open to interpretation, so that way the data would be stronger and potentially cleaner,” recommended another panel member.

Panelists suggested making the system more user friendly, in addition to having narrative descriptions that are more consistent across categories.

For example, one provider may use a description of “loose stool” while another would use the term “diarrhea.”

“I feel like I'm not serving the general public or the government of the United States, with the current information that I'm receiving. I am not capable of being assured in any way about safety with the [current] passive surveillance system. We have to get better information,” said Mary Glode, M.D., an infectious diseases specialist with the University of Colorado, Denver.

FDA representatives acknowledged that underreporting of adverse events and establishing causality are ongoing challenges under the current MedWatch system.

“There's a lot of missing information. We try to make the most out of this limited information. It's a good system to pick up some rare, serious events,” said an FDA representative.

The panelists also heard data compiled as part of the 1-year postexclusivity adverse event review program mandated by the Best Pharmaceuticals for Children Act.

Information was presented on the following medications:

Benazepril (Lotensin, Lotensin HCT, Lotrel).

▸ Approved: June 25, 1991, manufactured by Novartis.

▸ Indication: This antihypertensive (ACE inhibitor) is used to treat hypertension in patients over 6 years of age.

▸ Pediatric Adverse Events Reported: Three adverse events (AEs) in 1-year period reviewed, and five total since its approval; all were serious, none were fatal. No patterns discernible in the AEs for benazepril monotherapy. No AEs reported for benazepril's combination products.

▸ FDA Recommendation: Return to routine monitoring. The agency recommended routine monitoring of AEs, focusing on serious AEs in all populations, as opposed to giving special attention to all pediatric AEs reported as mandated by the 1-year exclusivity period.

▸ Panel Recommendation: The panel did not concur, and regarded the data presented as too inadequate for a return to routine monitoring. They recommended the FDA “look closely at all case reports for benazepril for yet another year and then report back to the committee,” said panel chair, P. Joan Chesney, M.D., an infectious diseases specialist and director of academic programs at St. Jude Children's Research Hospital, Memphis.

Esmolol (Brevibloc).

▸ Approved: December 31, 1986, manufactured by Baxter Laboratories.

▸ Indication: No pediatric indication. In adults, this β-1-selective (cardioselective) adrenergic receptor blocking agent is used to treat supraventricular tachycardia, intraoperative and postoperative tachycardia and/or hypertension.

▸ Pediatric Adverse Events Reported: During the 1-year postexclusivity period there was one pediatric AE reported. Since its approval there were 13 pediatric AEs reported (9 serious, 3 deaths). No discernible patterns in AEs.

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel did not concur, and regarded the data presented as insufficient. Recommended another year-long exclusivity period.

Orlistat (Xenical).

▸ Approved: April 23, 1999, manufactured by Roche.

▸ Indication: A lipase inhibitor for obesity management in conjunction with weight loss in patients aged 12 years and older with a body mass index greater than 30, or 27 with risk factors (hypertension, diabetes, dyslipidemia). Less than 1% (about 4,000) annual prescriptions for the drug were for pediatric patients.

▸ Pediatric Adverse Events Reported: Twenty-two pediatric AEs were reported (21 serious, no deaths). There was one serious AE reported during the 1-year postexclusivity period.

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel concurred.

Glyburide-Metformin (Glucovance).

▸ Approved: July 31, 2000, manufactured by Bristol-Myers Squibb Co.

▸ Indication: An antihyperglycemic for the adjunct treatment of type 2 diabetes mellitus along with diet and exercise, as well as a second-line treatment for type 2 diabetes if metformin or sulfonylurea fail. The glyburide stimulates release of insulin while the metformin improves glucose tolerance.

▸ Pediatric Adverse Events Reported: No AE reports in this population since Glucovance's approval. Both drugs have minimal use in pediatric patients.

▸ FDA Recommendation: Return to routine monitoring for the drug combo.

▸ Panel Recommendation: The panel concurred.

Atovaquone-Proguanil (Malarone Pediatric).

▸ Approved: July 14, 2000, manufactured by GlaxoSmithKline

▸ Indication: An antimalarial used in the treatment of Plasmodium falciparum malaria in patients over 5 kg and prophylaxis in patients over 1 kg.

▸ Pediatric Adverse Events Reported: Seven AEs were reported during the 1-year postexclusivity period (six serious, no deaths). There were 17 AEs reported since the drug's approval (15 serious, 3 deaths).

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel unanimously concurred.

Nelfinavir Mesylate (Viracept).

▸ Approved: March 14, 1997, manufactured by Pfizer Inc.

▸ Indication: A protease inhibitor indicated for the treatment of HIV infection in patients over 2 years of age. Accounted for about 16.4% of the 1.9 million prescriptions dispensed in this drug class from Sept. 2003 to Aug. 2004.

▸ Pediatric Adverse Events Reported: There were 377 AEs reported since the drug's approval (374 serious, 19 deaths). During the 1-year postexclusivity period, there were 30 AEs reported (30 serious, 2 deaths).

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel agreed.n

BALTIMORE – Highly sensitive teenage girls are more likely to develop depression in response to romantic stress, Shannon E. Daley, Ph.D., said at a meeting sponsored by the Society for Research on Adolescence.

In this longitudinal study, 87 girls were studied using questionnaires and telephone interviews; 21% were African American, and 79% were Hispanic. Data were collected 6 months apart, and the measuring tools used were the Structured Clinical Interview for DSM-IV, the Interpersonal Sensitivity Measure, the Chronic Strain Interview, and the Episodic Stress Interview.

Participants, who were 16 years old, were questioned about romantic life events, and their lifetime history of unipolar depression was evaluated at the start of the study. Chronic romantic stress was assessed over the 6-month follow-up period, along with any more depressive symptoms, Dr. Daley, of the University of Southern California, said in an interview.

Through logistic regression analyses, Dr. Daley and her colleague at the university, doctoral candidate Christie J. Rizzo, determined that interpersonal sensitivity moderated the relationship between episodic and chronic romantic stress and clinical depression.

“Girls who experience a heightened sensitivity to interpersonal processes are especially likely to become depressed when confronted with romantic stress or low-quality romantic relationships,” they said.

BALTIMORE – Highly sensitive teenage girls are more likely to develop depression in response to romantic stress, Shannon E. Daley, Ph.D., said at a meeting sponsored by the Society for Research on Adolescence.

In this longitudinal study, 87 girls were studied using questionnaires and telephone interviews; 21% were African American, and 79% were Hispanic. Data were collected 6 months apart, and the measuring tools used were the Structured Clinical Interview for DSM-IV, the Interpersonal Sensitivity Measure, the Chronic Strain Interview, and the Episodic Stress Interview.

Participants, who were 16 years old, were questioned about romantic life events, and their lifetime history of unipolar depression was evaluated at the start of the study. Chronic romantic stress was assessed over the 6-month follow-up period, along with any more depressive symptoms, Dr. Daley, of the University of Southern California, said in an interview.

Through logistic regression analyses, Dr. Daley and her colleague at the university, doctoral candidate Christie J. Rizzo, determined that interpersonal sensitivity moderated the relationship between episodic and chronic romantic stress and clinical depression.

“Girls who experience a heightened sensitivity to interpersonal processes are especially likely to become depressed when confronted with romantic stress or low-quality romantic relationships,” they said.

BALTIMORE – Highly sensitive teenage girls are more likely to develop depression in response to romantic stress, Shannon E. Daley, Ph.D., said at a meeting sponsored by the Society for Research on Adolescence.

In this longitudinal study, 87 girls were studied using questionnaires and telephone interviews; 21% were African American, and 79% were Hispanic. Data were collected 6 months apart, and the measuring tools used were the Structured Clinical Interview for DSM-IV, the Interpersonal Sensitivity Measure, the Chronic Strain Interview, and the Episodic Stress Interview.

Participants, who were 16 years old, were questioned about romantic life events, and their lifetime history of unipolar depression was evaluated at the start of the study. Chronic romantic stress was assessed over the 6-month follow-up period, along with any more depressive symptoms, Dr. Daley, of the University of Southern California, said in an interview.

Through logistic regression analyses, Dr. Daley and her colleague at the university, doctoral candidate Christie J. Rizzo, determined that interpersonal sensitivity moderated the relationship between episodic and chronic romantic stress and clinical depression.

“Girls who experience a heightened sensitivity to interpersonal processes are especially likely to become depressed when confronted with romantic stress or low-quality romantic relationships,” they said.

WASHINGTON — Uterine artery embolization resulted in similar short-term morbidity but greater long-term morbidity, compared with total laparoscopic hysterectomy, Lindsay Mains, M.D., and colleagues reported during the annual meeting of District VII of the American College of Obstetricians and Gynecologists.

The researchers conducted a nonrandomized, retrospective study at their institution, the Ochsner Clinic Foundation in New Orleans. and presented their findings in poster form at the meeting.

Over a 4-year-period, they compared the cases of 103 patients who chose uterine artery embolization (UAE) with 175 patients who elected to have total laparoscopic hysterectomy (TLH).

In addition to reviewing medical records, the researchers conducted telephone interviews to compare preoperative data, complication rates, readmission rates, length and severity of recovery, and need for more treatment.

Both groups in the study had comparable demographics and baseline characteristics.

There were no statistically significant differences reported between the UAE and TLH groups in intraoperative complication rates (2.8% vs. 2.9%), postoperative complication rates (5.7% vs. 3.9%), or readmission rates (6.9% vs. 2.9%). Both groups experienced similar lengths of recovery and postoperative pain, Dr. Mains, an ob.gyn. at the clinic, said in an interview.

However, UAE patients were significantly more likely to need further surgery, compared with the TLH patients (15.5% vs. 4.6%). The UAE patients expressed greater dissatisfaction with their choice than did members of the TLH (38.5% vs. 7.7%), saying they would opt for a different treatment if they had to do it over.

“When intraoperative complications, postoperative complications, need for readmission, need for further treatment, and failure to treat symptoms were combined to be described as 'clinical failures,' UAE resulted in significantly more clinical failures than did TLH,” the researchers concluded.

WASHINGTON — Uterine artery embolization resulted in similar short-term morbidity but greater long-term morbidity, compared with total laparoscopic hysterectomy, Lindsay Mains, M.D., and colleagues reported during the annual meeting of District VII of the American College of Obstetricians and Gynecologists.

The researchers conducted a nonrandomized, retrospective study at their institution, the Ochsner Clinic Foundation in New Orleans. and presented their findings in poster form at the meeting.

Over a 4-year-period, they compared the cases of 103 patients who chose uterine artery embolization (UAE) with 175 patients who elected to have total laparoscopic hysterectomy (TLH).

In addition to reviewing medical records, the researchers conducted telephone interviews to compare preoperative data, complication rates, readmission rates, length and severity of recovery, and need for more treatment.

Both groups in the study had comparable demographics and baseline characteristics.

There were no statistically significant differences reported between the UAE and TLH groups in intraoperative complication rates (2.8% vs. 2.9%), postoperative complication rates (5.7% vs. 3.9%), or readmission rates (6.9% vs. 2.9%). Both groups experienced similar lengths of recovery and postoperative pain, Dr. Mains, an ob.gyn. at the clinic, said in an interview.

However, UAE patients were significantly more likely to need further surgery, compared with the TLH patients (15.5% vs. 4.6%). The UAE patients expressed greater dissatisfaction with their choice than did members of the TLH (38.5% vs. 7.7%), saying they would opt for a different treatment if they had to do it over.

“When intraoperative complications, postoperative complications, need for readmission, need for further treatment, and failure to treat symptoms were combined to be described as 'clinical failures,' UAE resulted in significantly more clinical failures than did TLH,” the researchers concluded.

WASHINGTON — Uterine artery embolization resulted in similar short-term morbidity but greater long-term morbidity, compared with total laparoscopic hysterectomy, Lindsay Mains, M.D., and colleagues reported during the annual meeting of District VII of the American College of Obstetricians and Gynecologists.

The researchers conducted a nonrandomized, retrospective study at their institution, the Ochsner Clinic Foundation in New Orleans. and presented their findings in poster form at the meeting.

Over a 4-year-period, they compared the cases of 103 patients who chose uterine artery embolization (UAE) with 175 patients who elected to have total laparoscopic hysterectomy (TLH).

In addition to reviewing medical records, the researchers conducted telephone interviews to compare preoperative data, complication rates, readmission rates, length and severity of recovery, and need for more treatment.

Both groups in the study had comparable demographics and baseline characteristics.

There were no statistically significant differences reported between the UAE and TLH groups in intraoperative complication rates (2.8% vs. 2.9%), postoperative complication rates (5.7% vs. 3.9%), or readmission rates (6.9% vs. 2.9%). Both groups experienced similar lengths of recovery and postoperative pain, Dr. Mains, an ob.gyn. at the clinic, said in an interview.

However, UAE patients were significantly more likely to need further surgery, compared with the TLH patients (15.5% vs. 4.6%). The UAE patients expressed greater dissatisfaction with their choice than did members of the TLH (38.5% vs. 7.7%), saying they would opt for a different treatment if they had to do it over.

“When intraoperative complications, postoperative complications, need for readmission, need for further treatment, and failure to treat symptoms were combined to be described as 'clinical failures,' UAE resulted in significantly more clinical failures than did TLH,” the researchers concluded.

ROCKVILLE, MD. — The Food and Drug Administration's Pediatric Advisory Committee has recommended the addition of a black box warning to the prescription labels of topical formulations of pimecrolimus and tacrolimus because higher systemic exposure in children and infants may lead to malignancies. The topical agents are indicated for the treatment of mild to severe atopic dermatitis.

Pimecrolimus cream 1% (Elidel), manufactured by Novartis Pharmaceuticals, is indicated for short-term and long-term intermittent therapy for mild to moderate atopic dermatitis (AD) in nonimmunocompromised patients aged 2 years and older. Tacrolimus ointment (Protopic) is made by Fujisawa Healthcare Inc., and is indicated for moderate to severe AD. Only the 0.3% strength is approved for use in children aged 2 years and older. (Protopic is also available in a 1% strength.)

Both drugs are nonsteroidal, calcineurin inhibitors and immunosuppressants, with an unknown mechanism of action.

While neither drug is approved for children under age 2 years, according to FDA data collected between June 2003 and May 2004, almost 2 million prescriptions were dispensed to pediatric patients in the United States and patients aged 1–2 years accounted for 8% and 13% of all tacrolimus and pimecrolimus prescriptions, respectively. Prescriptions by nondermatologists now account for the majority of the use of pimecrolimus.

Inappropriate Prescribing

Panel members were adamant that these treatments should be used strictly as indicated, but recognized off-label prescribing as a problem. “As recently as a couple of weeks ago I had an 8-week old who had been treated with one of these. Whether it's indicated or not, it's happening,” said Roselyn Epps, M.D., chief of the division of dermatology at Children's National Medical Center, Washington.

“The increasing use may be related to aggressive and inappropriate advertising with portrayal of these products as safer than steroids and the implication that they can be used as first-line therapy and for unlimited periods of time,” Jean Temeck, M.D., acting medical team leader with the FDA, said in a written statement.

High blood levels of the agents are more frequently seen in children, says the FDA, and higher systemic exposure may be related to a greater surface area to mass ratio.

Since topical tacrolimus was approved in 2000 and topical pimecrolimus in 2001, there have been seven reported cases of lymphoma in patients. One was in a patient of unreported age, and one in a 2-year old.

Topical immunosuppressants may trigger malignancies by “breaking local immune surveillance resulting in skin cancers. [Tacrolimus and pimecrolimus] draining from atopic skin into regional lymph nodes may result in immunosuppression,” Bindi Nikhar, M.D., of the FDA's division of dermatologic and dental drugs, said at the meeting. She was critical of the “steroid-free” statements contained in aggressive direct-to-consumer advertising by the drug makers.

Black Box Alternatives

The panel debated several prescriber-targeted tactics, before voting for a black box warning. Suggestions of beefed up surveillance via a registry, professional organization letters with electronic alerts, and CME courses appeared problematic and insufficient. A “Dear Health Care Provider” letter was also deemed inadequate, as the committee wanted to be sure that the message of the increased cancer risk would be continuous and widespread.

A patient medication guide (MedGuide) dispensed by the pharmacy was preferred for patient-targeted information.

Manufacturers' Opposition

Drug company representatives strenuously objected and claimed the black box warning would be based primarily on animal studies. Novartis is conducting two large, long-term safety studies of pimecrolimus use in infants, with regular reviews by an independent body. The company is also in the midst of a 10-year registry study of children, with “yearly evaluation of the data.” For tacrolimus, there is a long-term “pharmaco-vigilance” study being conducted outside of the United States, and another long-term safety study going on in Europe. A 10-year, multinational registry study is being initiated this year focusing on tacrolimus and children, with regular evaluations for cutaneous and systemic malignancy risk.

In a prepared statement, Novartis agreed that “patients suffering from mild to moderate eczema need to be informed about the safe and effective use of Elidel Cream 1%, but we believe a recommendation to add a black box warning to the label is unsubstantiated by clinical evidence and experience in more than 5 million patients worldwide.”

The Panel's Concerns

“There is no evidence of systemic immune suppression or increased risk of malignancies,” said M. Joyce Rico, M.D., senior medical director with Fujisawa. “There is minimal blood absorption after topical application, and most patients have blood levels less than 0.5 ng/mL, with no systemic accumulation.”

However, the FDA gave several examples from adverse event reports of children with high blood levels of tacrolimus or pimecrolimus after the therapies were greatly reduced or halted. “The most significant case was that of an 8-month-old male who developed eczema herpeticum with Pseudomonas sepsis and subsequent cardiac arrest. Protopic ointment was applied over his entire body for 6 months. The serum tacrolimus level was 3.5 ng/mL 2 weeks after Protopic had been discontinued. The patient survived,” Dr. Temeck said.

The manufacturers maintain that no causal relationship has been proved between the ointments and malignancies; a position echoed in FDA documents.

Latency was another concern among the panel members, and they debated the possibility of serious adverse events developing several years after discontinued use. “If we are going to be observing lymphomas in this patient population, it's not going to be a spurt of B-cell lymphomas … there's going to be a longer period of observation that we need in order to conclusively say that we are going to see an increased incidence trait,” said Victor Santana, M.D., of the department of hematology/oncology at St. Jude Children's Research Hospital, Memphis. He also claimed the preclinical data were more convincing of causality.

Dr. Epps expressed further concern that health care providers without dermatologic experience may not provide adequate follow-up care for patients who have used the topical treatments, and that “many don't necessarily know what they're treating.” Specifically, there are skin syndromes for which pimecrolimus and tacrolimus should not be used. They include molluscum, ataxia-telangiectasia, syndromes with eczema, or those that already carry an increased risk of infection or malignancies.

One dissenting panel member said that a black box warning would exert an unnecessary burden on patients and consumers. “The human data presented don't convince me there's a clear risk … The data have not been collected for a sufficient length of time, but I'm weighing that against the argument that it could cause a lot of grief in the parents of the people who have to take these medications. That potential level of grief is unwarranted given the data,” said Dennis Bier, M.D., professor of pediatrics, Baylor College of Medicine, Houston.

ROCKVILLE, MD. — The Food and Drug Administration's Pediatric Advisory Committee has recommended the addition of a black box warning to the prescription labels of topical formulations of pimecrolimus and tacrolimus because higher systemic exposure in children and infants may lead to malignancies. The topical agents are indicated for the treatment of mild to severe atopic dermatitis.

Pimecrolimus cream 1% (Elidel), manufactured by Novartis Pharmaceuticals, is indicated for short-term and long-term intermittent therapy for mild to moderate atopic dermatitis (AD) in nonimmunocompromised patients aged 2 years and older. Tacrolimus ointment (Protopic) is made by Fujisawa Healthcare Inc., and is indicated for moderate to severe AD. Only the 0.3% strength is approved for use in children aged 2 years and older. (Protopic is also available in a 1% strength.)

Both drugs are nonsteroidal, calcineurin inhibitors and immunosuppressants, with an unknown mechanism of action.

While neither drug is approved for children under age 2 years, according to FDA data collected between June 2003 and May 2004, almost 2 million prescriptions were dispensed to pediatric patients in the United States and patients aged 1–2 years accounted for 8% and 13% of all tacrolimus and pimecrolimus prescriptions, respectively. Prescriptions by nondermatologists now account for the majority of the use of pimecrolimus.

Inappropriate Prescribing

Panel members were adamant that these treatments should be used strictly as indicated, but recognized off-label prescribing as a problem. “As recently as a couple of weeks ago I had an 8-week old who had been treated with one of these. Whether it's indicated or not, it's happening,” said Roselyn Epps, M.D., chief of the division of dermatology at Children's National Medical Center, Washington.

“The increasing use may be related to aggressive and inappropriate advertising with portrayal of these products as safer than steroids and the implication that they can be used as first-line therapy and for unlimited periods of time,” Jean Temeck, M.D., acting medical team leader with the FDA, said in a written statement.

High blood levels of the agents are more frequently seen in children, says the FDA, and higher systemic exposure may be related to a greater surface area to mass ratio.

Since topical tacrolimus was approved in 2000 and topical pimecrolimus in 2001, there have been seven reported cases of lymphoma in patients. One was in a patient of unreported age, and one in a 2-year old.

Topical immunosuppressants may trigger malignancies by “breaking local immune surveillance resulting in skin cancers. [Tacrolimus and pimecrolimus] draining from atopic skin into regional lymph nodes may result in immunosuppression,” Bindi Nikhar, M.D., of the FDA's division of dermatologic and dental drugs, said at the meeting. She was critical of the “steroid-free” statements contained in aggressive direct-to-consumer advertising by the drug makers.

Black Box Alternatives

The panel debated several prescriber-targeted tactics, before voting for a black box warning. Suggestions of beefed up surveillance via a registry, professional organization letters with electronic alerts, and CME courses appeared problematic and insufficient. A “Dear Health Care Provider” letter was also deemed inadequate, as the committee wanted to be sure that the message of the increased cancer risk would be continuous and widespread.

A patient medication guide (MedGuide) dispensed by the pharmacy was preferred for patient-targeted information.

Manufacturers' Opposition

Drug company representatives strenuously objected and claimed the black box warning would be based primarily on animal studies. Novartis is conducting two large, long-term safety studies of pimecrolimus use in infants, with regular reviews by an independent body. The company is also in the midst of a 10-year registry study of children, with “yearly evaluation of the data.” For tacrolimus, there is a long-term “pharmaco-vigilance” study being conducted outside of the United States, and another long-term safety study going on in Europe. A 10-year, multinational registry study is being initiated this year focusing on tacrolimus and children, with regular evaluations for cutaneous and systemic malignancy risk.

In a prepared statement, Novartis agreed that “patients suffering from mild to moderate eczema need to be informed about the safe and effective use of Elidel Cream 1%, but we believe a recommendation to add a black box warning to the label is unsubstantiated by clinical evidence and experience in more than 5 million patients worldwide.”

The Panel's Concerns

“There is no evidence of systemic immune suppression or increased risk of malignancies,” said M. Joyce Rico, M.D., senior medical director with Fujisawa. “There is minimal blood absorption after topical application, and most patients have blood levels less than 0.5 ng/mL, with no systemic accumulation.”

However, the FDA gave several examples from adverse event reports of children with high blood levels of tacrolimus or pimecrolimus after the therapies were greatly reduced or halted. “The most significant case was that of an 8-month-old male who developed eczema herpeticum with Pseudomonas sepsis and subsequent cardiac arrest. Protopic ointment was applied over his entire body for 6 months. The serum tacrolimus level was 3.5 ng/mL 2 weeks after Protopic had been discontinued. The patient survived,” Dr. Temeck said.

The manufacturers maintain that no causal relationship has been proved between the ointments and malignancies; a position echoed in FDA documents.

Latency was another concern among the panel members, and they debated the possibility of serious adverse events developing several years after discontinued use. “If we are going to be observing lymphomas in this patient population, it's not going to be a spurt of B-cell lymphomas … there's going to be a longer period of observation that we need in order to conclusively say that we are going to see an increased incidence trait,” said Victor Santana, M.D., of the department of hematology/oncology at St. Jude Children's Research Hospital, Memphis. He also claimed the preclinical data were more convincing of causality.

Dr. Epps expressed further concern that health care providers without dermatologic experience may not provide adequate follow-up care for patients who have used the topical treatments, and that “many don't necessarily know what they're treating.” Specifically, there are skin syndromes for which pimecrolimus and tacrolimus should not be used. They include molluscum, ataxia-telangiectasia, syndromes with eczema, or those that already carry an increased risk of infection or malignancies.

One dissenting panel member said that a black box warning would exert an unnecessary burden on patients and consumers. “The human data presented don't convince me there's a clear risk … The data have not been collected for a sufficient length of time, but I'm weighing that against the argument that it could cause a lot of grief in the parents of the people who have to take these medications. That potential level of grief is unwarranted given the data,” said Dennis Bier, M.D., professor of pediatrics, Baylor College of Medicine, Houston.

ROCKVILLE, MD. — The Food and Drug Administration's Pediatric Advisory Committee has recommended the addition of a black box warning to the prescription labels of topical formulations of pimecrolimus and tacrolimus because higher systemic exposure in children and infants may lead to malignancies. The topical agents are indicated for the treatment of mild to severe atopic dermatitis.

Pimecrolimus cream 1% (Elidel), manufactured by Novartis Pharmaceuticals, is indicated for short-term and long-term intermittent therapy for mild to moderate atopic dermatitis (AD) in nonimmunocompromised patients aged 2 years and older. Tacrolimus ointment (Protopic) is made by Fujisawa Healthcare Inc., and is indicated for moderate to severe AD. Only the 0.3% strength is approved for use in children aged 2 years and older. (Protopic is also available in a 1% strength.)

Both drugs are nonsteroidal, calcineurin inhibitors and immunosuppressants, with an unknown mechanism of action.

While neither drug is approved for children under age 2 years, according to FDA data collected between June 2003 and May 2004, almost 2 million prescriptions were dispensed to pediatric patients in the United States and patients aged 1–2 years accounted for 8% and 13% of all tacrolimus and pimecrolimus prescriptions, respectively. Prescriptions by nondermatologists now account for the majority of the use of pimecrolimus.

Inappropriate Prescribing

Panel members were adamant that these treatments should be used strictly as indicated, but recognized off-label prescribing as a problem. “As recently as a couple of weeks ago I had an 8-week old who had been treated with one of these. Whether it's indicated or not, it's happening,” said Roselyn Epps, M.D., chief of the division of dermatology at Children's National Medical Center, Washington.

“The increasing use may be related to aggressive and inappropriate advertising with portrayal of these products as safer than steroids and the implication that they can be used as first-line therapy and for unlimited periods of time,” Jean Temeck, M.D., acting medical team leader with the FDA, said in a written statement.

High blood levels of the agents are more frequently seen in children, says the FDA, and higher systemic exposure may be related to a greater surface area to mass ratio.

Since topical tacrolimus was approved in 2000 and topical pimecrolimus in 2001, there have been seven reported cases of lymphoma in patients. One was in a patient of unreported age, and one in a 2-year old.

Topical immunosuppressants may trigger malignancies by “breaking local immune surveillance resulting in skin cancers. [Tacrolimus and pimecrolimus] draining from atopic skin into regional lymph nodes may result in immunosuppression,” Bindi Nikhar, M.D., of the FDA's division of dermatologic and dental drugs, said at the meeting. She was critical of the “steroid-free” statements contained in aggressive direct-to-consumer advertising by the drug makers.

Black Box Alternatives

The panel debated several prescriber-targeted tactics, before voting for a black box warning. Suggestions of beefed up surveillance via a registry, professional organization letters with electronic alerts, and CME courses appeared problematic and insufficient. A “Dear Health Care Provider” letter was also deemed inadequate, as the committee wanted to be sure that the message of the increased cancer risk would be continuous and widespread.

A patient medication guide (MedGuide) dispensed by the pharmacy was preferred for patient-targeted information.

Manufacturers' Opposition

Drug company representatives strenuously objected and claimed the black box warning would be based primarily on animal studies. Novartis is conducting two large, long-term safety studies of pimecrolimus use in infants, with regular reviews by an independent body. The company is also in the midst of a 10-year registry study of children, with “yearly evaluation of the data.” For tacrolimus, there is a long-term “pharmaco-vigilance” study being conducted outside of the United States, and another long-term safety study going on in Europe. A 10-year, multinational registry study is being initiated this year focusing on tacrolimus and children, with regular evaluations for cutaneous and systemic malignancy risk.

In a prepared statement, Novartis agreed that “patients suffering from mild to moderate eczema need to be informed about the safe and effective use of Elidel Cream 1%, but we believe a recommendation to add a black box warning to the label is unsubstantiated by clinical evidence and experience in more than 5 million patients worldwide.”

The Panel's Concerns

“There is no evidence of systemic immune suppression or increased risk of malignancies,” said M. Joyce Rico, M.D., senior medical director with Fujisawa. “There is minimal blood absorption after topical application, and most patients have blood levels less than 0.5 ng/mL, with no systemic accumulation.”

However, the FDA gave several examples from adverse event reports of children with high blood levels of tacrolimus or pimecrolimus after the therapies were greatly reduced or halted. “The most significant case was that of an 8-month-old male who developed eczema herpeticum with Pseudomonas sepsis and subsequent cardiac arrest. Protopic ointment was applied over his entire body for 6 months. The serum tacrolimus level was 3.5 ng/mL 2 weeks after Protopic had been discontinued. The patient survived,” Dr. Temeck said.

The manufacturers maintain that no causal relationship has been proved between the ointments and malignancies; a position echoed in FDA documents.

Latency was another concern among the panel members, and they debated the possibility of serious adverse events developing several years after discontinued use. “If we are going to be observing lymphomas in this patient population, it's not going to be a spurt of B-cell lymphomas … there's going to be a longer period of observation that we need in order to conclusively say that we are going to see an increased incidence trait,” said Victor Santana, M.D., of the department of hematology/oncology at St. Jude Children's Research Hospital, Memphis. He also claimed the preclinical data were more convincing of causality.

Dr. Epps expressed further concern that health care providers without dermatologic experience may not provide adequate follow-up care for patients who have used the topical treatments, and that “many don't necessarily know what they're treating.” Specifically, there are skin syndromes for which pimecrolimus and tacrolimus should not be used. They include molluscum, ataxia-telangiectasia, syndromes with eczema, or those that already carry an increased risk of infection or malignancies.

One dissenting panel member said that a black box warning would exert an unnecessary burden on patients and consumers. “The human data presented don't convince me there's a clear risk … The data have not been collected for a sufficient length of time, but I'm weighing that against the argument that it could cause a lot of grief in the parents of the people who have to take these medications. That potential level of grief is unwarranted given the data,” said Dennis Bier, M.D., professor of pediatrics, Baylor College of Medicine, Houston.

BOSTON — A few adjustments might be needed to make your practice approachable and comfortable for adolescent patients, but the long-term payoffs can be worth it.

“Why is it some people aren't so comfortable taking care of adolescents? They think they take more time in the office. They have varied issues. It's sometimes challenging, and a lot of ob.gyn. residency programs didn't address pediatric or adolescent gynecology specifically, Marc Laufer, M.D., said at an ob.gyn. meeting sponsored by Harvard Medical School.

“We're aware of that, and we're trying to address it through the American College of Obstetricians and Gynecologists and the North American Society for Pediatric and Adolescent Gynecology [NASPAG],” said Dr. Laufer of Harvard and chief of gynecology at Children's Hospital Boston.

Confidentiality is “one of the key issues” in making a practice more friendly for adolescents. One critical move is to make sure sound doesn't carry. If office walls aren't soundproof, Dr. Laufer suggested using sound machines, such as white noise machines or sound conditioners, which can help mask sounds between offices.

A lot of care for these patients can be conducted by their primary care providers. But when it comes to certain diseases, “if we treat and diagnose them when people are younger, we may improve their long-term health care,” Dr. Laufer said at the meeting cosponsored by Brigham and Women's Hospital. Dr. Laufer said if polycystic ovary syndrome were diagnosed and treated during adolescence, there would be a greater chance of decreasing rates of obesity and diabetes. The same holds for endometriosis. An early diagnosis likely would result in less pelvic pain over the patient's lifetime and lead to improved long-term fertility.

Since most adolescents are “Internet savvy,” Dr. Laufer encouraged physicians to direct young patients to online resources such as the Web site by the Center for Young Women's Health at Children's Hospital Boston (www.youngwomenshealth.org

The NASPAG's Web site (www.naspag.org

BOSTON — A few adjustments might be needed to make your practice approachable and comfortable for adolescent patients, but the long-term payoffs can be worth it.

“Why is it some people aren't so comfortable taking care of adolescents? They think they take more time in the office. They have varied issues. It's sometimes challenging, and a lot of ob.gyn. residency programs didn't address pediatric or adolescent gynecology specifically, Marc Laufer, M.D., said at an ob.gyn. meeting sponsored by Harvard Medical School.

“We're aware of that, and we're trying to address it through the American College of Obstetricians and Gynecologists and the North American Society for Pediatric and Adolescent Gynecology [NASPAG],” said Dr. Laufer of Harvard and chief of gynecology at Children's Hospital Boston.

Confidentiality is “one of the key issues” in making a practice more friendly for adolescents. One critical move is to make sure sound doesn't carry. If office walls aren't soundproof, Dr. Laufer suggested using sound machines, such as white noise machines or sound conditioners, which can help mask sounds between offices.

A lot of care for these patients can be conducted by their primary care providers. But when it comes to certain diseases, “if we treat and diagnose them when people are younger, we may improve their long-term health care,” Dr. Laufer said at the meeting cosponsored by Brigham and Women's Hospital. Dr. Laufer said if polycystic ovary syndrome were diagnosed and treated during adolescence, there would be a greater chance of decreasing rates of obesity and diabetes. The same holds for endometriosis. An early diagnosis likely would result in less pelvic pain over the patient's lifetime and lead to improved long-term fertility.

Since most adolescents are “Internet savvy,” Dr. Laufer encouraged physicians to direct young patients to online resources such as the Web site by the Center for Young Women's Health at Children's Hospital Boston (www.youngwomenshealth.org

The NASPAG's Web site (www.naspag.org

BOSTON — A few adjustments might be needed to make your practice approachable and comfortable for adolescent patients, but the long-term payoffs can be worth it.

“Why is it some people aren't so comfortable taking care of adolescents? They think they take more time in the office. They have varied issues. It's sometimes challenging, and a lot of ob.gyn. residency programs didn't address pediatric or adolescent gynecology specifically, Marc Laufer, M.D., said at an ob.gyn. meeting sponsored by Harvard Medical School.

“We're aware of that, and we're trying to address it through the American College of Obstetricians and Gynecologists and the North American Society for Pediatric and Adolescent Gynecology [NASPAG],” said Dr. Laufer of Harvard and chief of gynecology at Children's Hospital Boston.

Confidentiality is “one of the key issues” in making a practice more friendly for adolescents. One critical move is to make sure sound doesn't carry. If office walls aren't soundproof, Dr. Laufer suggested using sound machines, such as white noise machines or sound conditioners, which can help mask sounds between offices.

A lot of care for these patients can be conducted by their primary care providers. But when it comes to certain diseases, “if we treat and diagnose them when people are younger, we may improve their long-term health care,” Dr. Laufer said at the meeting cosponsored by Brigham and Women's Hospital. Dr. Laufer said if polycystic ovary syndrome were diagnosed and treated during adolescence, there would be a greater chance of decreasing rates of obesity and diabetes. The same holds for endometriosis. An early diagnosis likely would result in less pelvic pain over the patient's lifetime and lead to improved long-term fertility.

Since most adolescents are “Internet savvy,” Dr. Laufer encouraged physicians to direct young patients to online resources such as the Web site by the Center for Young Women's Health at Children's Hospital Boston (www.youngwomenshealth.org

The NASPAG's Web site (www.naspag.org

WASHINGTON — Elective induction did not adversely affect the cesarean-section rate or maternal fetal morbidity in a retrospective cohort study of 361 nulliparous patients.

The women, who were at 37-41 weeks' gestation, were delivered from January 1998 to December 1999 at the Ochsner Clinic Foundation in New Orleans. The women had singleton pregnancies and no medical indications for delivery, David J. Bonilla, M.D., reported in a poster at the annual meeting of District VII of the American College of Obstetricians and Gynecologists.

The women were divided two groups: a spontaneous labor group and a group that had elective induction with a favorable cervix (Bishop score of at least 5), reported Dr. Bonilla of the clinic.

The C-section rate was almost 10% in the group of 114 patients who had elective induction with a favorable cervix, compared with 17% in the 247 patients who had spontaneous labor.

The induction group had a significantly higher rate of instrumental delivery, compared with the spontaneous labor group, 32% vs. 23%. There was a slight increase in admissions to the neonatal ICU in the elective induction group (1.45% vs. 3.23%), but it was not significant. Elective induction did not impact other outcome variables in relation to fetal morbidity

WASHINGTON — Elective induction did not adversely affect the cesarean-section rate or maternal fetal morbidity in a retrospective cohort study of 361 nulliparous patients.

The women, who were at 37-41 weeks' gestation, were delivered from January 1998 to December 1999 at the Ochsner Clinic Foundation in New Orleans. The women had singleton pregnancies and no medical indications for delivery, David J. Bonilla, M.D., reported in a poster at the annual meeting of District VII of the American College of Obstetricians and Gynecologists.

The women were divided two groups: a spontaneous labor group and a group that had elective induction with a favorable cervix (Bishop score of at least 5), reported Dr. Bonilla of the clinic.

The C-section rate was almost 10% in the group of 114 patients who had elective induction with a favorable cervix, compared with 17% in the 247 patients who had spontaneous labor.

The induction group had a significantly higher rate of instrumental delivery, compared with the spontaneous labor group, 32% vs. 23%. There was a slight increase in admissions to the neonatal ICU in the elective induction group (1.45% vs. 3.23%), but it was not significant. Elective induction did not impact other outcome variables in relation to fetal morbidity

WASHINGTON — Elective induction did not adversely affect the cesarean-section rate or maternal fetal morbidity in a retrospective cohort study of 361 nulliparous patients.

The women, who were at 37-41 weeks' gestation, were delivered from January 1998 to December 1999 at the Ochsner Clinic Foundation in New Orleans. The women had singleton pregnancies and no medical indications for delivery, David J. Bonilla, M.D., reported in a poster at the annual meeting of District VII of the American College of Obstetricians and Gynecologists.

The women were divided two groups: a spontaneous labor group and a group that had elective induction with a favorable cervix (Bishop score of at least 5), reported Dr. Bonilla of the clinic.

The C-section rate was almost 10% in the group of 114 patients who had elective induction with a favorable cervix, compared with 17% in the 247 patients who had spontaneous labor.

The induction group had a significantly higher rate of instrumental delivery, compared with the spontaneous labor group, 32% vs. 23%. There was a slight increase in admissions to the neonatal ICU in the elective induction group (1.45% vs. 3.23%), but it was not significant. Elective induction did not impact other outcome variables in relation to fetal morbidity