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Osamu recalls tuna following 62 salmonella cases
Osamu Corp. announced that it has voluntarily recalled frozen yellow tuna from a processing plant in Indonesia after 62 people become infected with Salmonella Paratyphi B variant L(+) tartrate(+) bacteria in the United States, according to the Centers for Disease Control and Prevention
“Epidemiologic and laboratory findings indicate that frozen tuna is the likely source of the infections,” with most of the victims having reported eating sushi made from raw tuna in the week prior to becoming sick, stated the CDC.
Symptoms of the disease typically include diarrhea, fever, and abdominal cramps 12-72 hours after an exposure. Of those infected during this outbreak, 11 were hospitalized and none died, according to the CDC.
Cases of this outbreak have been reported from 11 states, with illness onset dates having begun in March. The two most recent victims became infected with the bacteria after the CDC’s July 15 update on the outbreak.
Osamu has recalled the following:
• All frozen yellowfin tuna (loin, saku, chunk, slice, and ground market forms) sold to restaurants and grocery stories throughout the United States from May 9, 2014, to July 9, 2015. Affected products can be identified by four-digit purchase order numbers 8563 through 8599 located on each product carton box.
• One lot of frozen yellowfin tuna chunk meat distributed to AFC Corp. for use in sushi franchises in grocery stores throughout the United States from May 20, 2015, to May 26, 2015, after the Minnesota Department of Health and the Department of Agriculture isolated the outbreak strain from samples of unopened frozen raw tuna collected from a Minnesota grocery store where an ill person in this outbreak reported eating tuna sushi. The affected lot can be identified by lot number 68568.
The CDC instructs restaurants and retailers who do not know the lot number of frozen tuna in their freezers to contact the distributor and to avoid serving or selling any tuna unless they are certain it has not been recalled.
Restaurants and retailers can reach Osamu at 1-310-849-8881, Monday through Friday from 8:00 a.m. to 5:00 p.m., PDT.
The CDC advises consumers that raw fish or raw shellfish should to be consumed by anyone at high risk for serious food-borne illness, including children under 5 years, adults older than 65 years, pregnant women, and anyone with a weakened immune system.
Osamu Corp. announced that it has voluntarily recalled frozen yellow tuna from a processing plant in Indonesia after 62 people become infected with Salmonella Paratyphi B variant L(+) tartrate(+) bacteria in the United States, according to the Centers for Disease Control and Prevention
“Epidemiologic and laboratory findings indicate that frozen tuna is the likely source of the infections,” with most of the victims having reported eating sushi made from raw tuna in the week prior to becoming sick, stated the CDC.
Symptoms of the disease typically include diarrhea, fever, and abdominal cramps 12-72 hours after an exposure. Of those infected during this outbreak, 11 were hospitalized and none died, according to the CDC.
Cases of this outbreak have been reported from 11 states, with illness onset dates having begun in March. The two most recent victims became infected with the bacteria after the CDC’s July 15 update on the outbreak.
Osamu has recalled the following:
• All frozen yellowfin tuna (loin, saku, chunk, slice, and ground market forms) sold to restaurants and grocery stories throughout the United States from May 9, 2014, to July 9, 2015. Affected products can be identified by four-digit purchase order numbers 8563 through 8599 located on each product carton box.
• One lot of frozen yellowfin tuna chunk meat distributed to AFC Corp. for use in sushi franchises in grocery stores throughout the United States from May 20, 2015, to May 26, 2015, after the Minnesota Department of Health and the Department of Agriculture isolated the outbreak strain from samples of unopened frozen raw tuna collected from a Minnesota grocery store where an ill person in this outbreak reported eating tuna sushi. The affected lot can be identified by lot number 68568.
The CDC instructs restaurants and retailers who do not know the lot number of frozen tuna in their freezers to contact the distributor and to avoid serving or selling any tuna unless they are certain it has not been recalled.
Restaurants and retailers can reach Osamu at 1-310-849-8881, Monday through Friday from 8:00 a.m. to 5:00 p.m., PDT.
The CDC advises consumers that raw fish or raw shellfish should to be consumed by anyone at high risk for serious food-borne illness, including children under 5 years, adults older than 65 years, pregnant women, and anyone with a weakened immune system.
Osamu Corp. announced that it has voluntarily recalled frozen yellow tuna from a processing plant in Indonesia after 62 people become infected with Salmonella Paratyphi B variant L(+) tartrate(+) bacteria in the United States, according to the Centers for Disease Control and Prevention
“Epidemiologic and laboratory findings indicate that frozen tuna is the likely source of the infections,” with most of the victims having reported eating sushi made from raw tuna in the week prior to becoming sick, stated the CDC.
Symptoms of the disease typically include diarrhea, fever, and abdominal cramps 12-72 hours after an exposure. Of those infected during this outbreak, 11 were hospitalized and none died, according to the CDC.
Cases of this outbreak have been reported from 11 states, with illness onset dates having begun in March. The two most recent victims became infected with the bacteria after the CDC’s July 15 update on the outbreak.
Osamu has recalled the following:
• All frozen yellowfin tuna (loin, saku, chunk, slice, and ground market forms) sold to restaurants and grocery stories throughout the United States from May 9, 2014, to July 9, 2015. Affected products can be identified by four-digit purchase order numbers 8563 through 8599 located on each product carton box.
• One lot of frozen yellowfin tuna chunk meat distributed to AFC Corp. for use in sushi franchises in grocery stores throughout the United States from May 20, 2015, to May 26, 2015, after the Minnesota Department of Health and the Department of Agriculture isolated the outbreak strain from samples of unopened frozen raw tuna collected from a Minnesota grocery store where an ill person in this outbreak reported eating tuna sushi. The affected lot can be identified by lot number 68568.
The CDC instructs restaurants and retailers who do not know the lot number of frozen tuna in their freezers to contact the distributor and to avoid serving or selling any tuna unless they are certain it has not been recalled.
Restaurants and retailers can reach Osamu at 1-310-849-8881, Monday through Friday from 8:00 a.m. to 5:00 p.m., PDT.
The CDC advises consumers that raw fish or raw shellfish should to be consumed by anyone at high risk for serious food-borne illness, including children under 5 years, adults older than 65 years, pregnant women, and anyone with a weakened immune system.
Pain, quality of life measures improve more in OA than RA after knee arthroplasty
Total knee arthroplasty provides osteoarthritis patients with greater improvement in pain and health-related quality of life than it does for rheumatoid arthritis patients, possibly relating to the lower pain and younger age of RA patients at the time of surgery, according to a study based on patients’ responses to semiannual questionnaires.
The study included 834 patients diagnosed with RA and 315 patients diagnosed with osteoarthritis (OA), who had a primary total knee arthroplasty (TKA) between Jan. 1, 1999, and June 30, 2012. The patients were probed on their demographic characteristics, disease duration, mental health, functional status, health-related quality of life (HRQoL), pain, and usage of pain medication. All study participants participated in at least three consecutive sampling intervals: a 6-month preoperative period, a 6-month immediate postoperative period, and a subsequent 6-month “recovery” period. Of the patients who underwent a TKA, 144 (11%) did not complete all three sampling intervals.
At baseline, compared with OA patients, RA patients had significantly less severe scores for measures of pain, lesser usage of pain medications, and significantly more severe scores for measures of disease activity.
After recovering from a TKA, the RA and OA patients improved in almost all outcome measures of pain, function, and HRQoL. The surgery had a larger beneficial effect in OA patients than in RA patients for all measures of pain and HRQoL indices, except for the RA disease activity index (RADAI)/total joint count. In contrast to the OA patients, RA patients showed greater improvements in joint involvement.
For both groups, all outcome measures of pain and function worsened a year before TKA and improved immediately after the surgery; however, the improvement leveled off in the 6-12 months after the procedure.
“After adjusting for preoperative variables, post TKA, a diagnosis of RA (vs. OA) (P = .03), income (P < .01), and anxiety (P = .03) were most useful in predicting the reduction in [visual analog scale] pain scores,” noted Dr. Anand Dusad of the Veterans Affairs Nebraska–Western Iowa Health Care System, Omaha, and his colleagues.
“In summary, using a large cohort of arthritis patients, we have shown that TKA is performed in patients with severe disease and leads to marked improvements in pain function and HRQoL,” according to the researchers.
Read the full study published online July 20 in Arthritis & Rheumatology (doi:10.1002/art.39221).
Total knee arthroplasty provides osteoarthritis patients with greater improvement in pain and health-related quality of life than it does for rheumatoid arthritis patients, possibly relating to the lower pain and younger age of RA patients at the time of surgery, according to a study based on patients’ responses to semiannual questionnaires.
The study included 834 patients diagnosed with RA and 315 patients diagnosed with osteoarthritis (OA), who had a primary total knee arthroplasty (TKA) between Jan. 1, 1999, and June 30, 2012. The patients were probed on their demographic characteristics, disease duration, mental health, functional status, health-related quality of life (HRQoL), pain, and usage of pain medication. All study participants participated in at least three consecutive sampling intervals: a 6-month preoperative period, a 6-month immediate postoperative period, and a subsequent 6-month “recovery” period. Of the patients who underwent a TKA, 144 (11%) did not complete all three sampling intervals.
At baseline, compared with OA patients, RA patients had significantly less severe scores for measures of pain, lesser usage of pain medications, and significantly more severe scores for measures of disease activity.
After recovering from a TKA, the RA and OA patients improved in almost all outcome measures of pain, function, and HRQoL. The surgery had a larger beneficial effect in OA patients than in RA patients for all measures of pain and HRQoL indices, except for the RA disease activity index (RADAI)/total joint count. In contrast to the OA patients, RA patients showed greater improvements in joint involvement.
For both groups, all outcome measures of pain and function worsened a year before TKA and improved immediately after the surgery; however, the improvement leveled off in the 6-12 months after the procedure.
“After adjusting for preoperative variables, post TKA, a diagnosis of RA (vs. OA) (P = .03), income (P < .01), and anxiety (P = .03) were most useful in predicting the reduction in [visual analog scale] pain scores,” noted Dr. Anand Dusad of the Veterans Affairs Nebraska–Western Iowa Health Care System, Omaha, and his colleagues.
“In summary, using a large cohort of arthritis patients, we have shown that TKA is performed in patients with severe disease and leads to marked improvements in pain function and HRQoL,” according to the researchers.
Read the full study published online July 20 in Arthritis & Rheumatology (doi:10.1002/art.39221).
Total knee arthroplasty provides osteoarthritis patients with greater improvement in pain and health-related quality of life than it does for rheumatoid arthritis patients, possibly relating to the lower pain and younger age of RA patients at the time of surgery, according to a study based on patients’ responses to semiannual questionnaires.
The study included 834 patients diagnosed with RA and 315 patients diagnosed with osteoarthritis (OA), who had a primary total knee arthroplasty (TKA) between Jan. 1, 1999, and June 30, 2012. The patients were probed on their demographic characteristics, disease duration, mental health, functional status, health-related quality of life (HRQoL), pain, and usage of pain medication. All study participants participated in at least three consecutive sampling intervals: a 6-month preoperative period, a 6-month immediate postoperative period, and a subsequent 6-month “recovery” period. Of the patients who underwent a TKA, 144 (11%) did not complete all three sampling intervals.
At baseline, compared with OA patients, RA patients had significantly less severe scores for measures of pain, lesser usage of pain medications, and significantly more severe scores for measures of disease activity.
After recovering from a TKA, the RA and OA patients improved in almost all outcome measures of pain, function, and HRQoL. The surgery had a larger beneficial effect in OA patients than in RA patients for all measures of pain and HRQoL indices, except for the RA disease activity index (RADAI)/total joint count. In contrast to the OA patients, RA patients showed greater improvements in joint involvement.
For both groups, all outcome measures of pain and function worsened a year before TKA and improved immediately after the surgery; however, the improvement leveled off in the 6-12 months after the procedure.
“After adjusting for preoperative variables, post TKA, a diagnosis of RA (vs. OA) (P = .03), income (P < .01), and anxiety (P = .03) were most useful in predicting the reduction in [visual analog scale] pain scores,” noted Dr. Anand Dusad of the Veterans Affairs Nebraska–Western Iowa Health Care System, Omaha, and his colleagues.
“In summary, using a large cohort of arthritis patients, we have shown that TKA is performed in patients with severe disease and leads to marked improvements in pain function and HRQoL,” according to the researchers.
Read the full study published online July 20 in Arthritis & Rheumatology (doi:10.1002/art.39221).
FROM ARTHRITIS & RHEUMATOLOGY
Reducing soda consumption could mean lower type 2 diabetes incidence
Drinking sugar-sweetened beverages is associated with a greater incidence of type 2 diabetes, independent of obesity, according to a systematic review and meta-analysis.
The researchers analyzed data from prospective design studies that assessed the consumption of beverages and incident type 2 diabetes, recruited adults free of diabetes, and followed study participants for at least 2 years. The data came from 17 cohorts comprising 38,253 cases of type 2 diabetes over 10,126,756 person-years. Using risk estimates, sampling weights, and population size, the researchers estimated the absolute number of incidents of type 2 diabetes over 10 years, the number of incidents of type 2 diabetes attributable to consumption of sugar-sweetened beverages, and the proportion of the disease incidents attributable to drinking of sugar-sweetened beverages. These estimations assumed causality and no change in individuals’ characteristics over time.
Higher consumption of sugar-sweetened beverages by one serving per day was associated with an 18% greater incidence of type 2 diabetes (95% confidence interval, 8.8%-28%; I2 [for heterogeneity] = 89%), before adjustment for adiposity. When adjusted for potential mediation and confounding by adiposity, the association was weakened to a 13% greater incidence of the disease.
Associations between drinking of artificially sweetened beverages and fruit juice were also found, but findings for artificially sweetened beverages were likely affected by publication bias and residual confounding; for fruit juice, the positive association was not stable and sensitive to study design.
“Under assumption of causality for the association of consumption of sugar-sweetened beverages with incident type 2 diabetes, we provided efficacy estimates that over 10 years two million type 2 diabetes events in the U.S. and 80,000 in the U.K. would be related to consumption of sugar-sweetened beverages,” according to Dr. Fumiaki Imamura of the University of Cambridge School of Clinical Medicine, and his colleagues.
“Future work should seek to improve precision of evidence and characterize efficacy and effectiveness of policy interventions for different populations,” according to the researchers.
Read the full study in the BMJ (doi:10.1136/bmj.h3576).
Drinking sugar-sweetened beverages is associated with a greater incidence of type 2 diabetes, independent of obesity, according to a systematic review and meta-analysis.
The researchers analyzed data from prospective design studies that assessed the consumption of beverages and incident type 2 diabetes, recruited adults free of diabetes, and followed study participants for at least 2 years. The data came from 17 cohorts comprising 38,253 cases of type 2 diabetes over 10,126,756 person-years. Using risk estimates, sampling weights, and population size, the researchers estimated the absolute number of incidents of type 2 diabetes over 10 years, the number of incidents of type 2 diabetes attributable to consumption of sugar-sweetened beverages, and the proportion of the disease incidents attributable to drinking of sugar-sweetened beverages. These estimations assumed causality and no change in individuals’ characteristics over time.
Higher consumption of sugar-sweetened beverages by one serving per day was associated with an 18% greater incidence of type 2 diabetes (95% confidence interval, 8.8%-28%; I2 [for heterogeneity] = 89%), before adjustment for adiposity. When adjusted for potential mediation and confounding by adiposity, the association was weakened to a 13% greater incidence of the disease.
Associations between drinking of artificially sweetened beverages and fruit juice were also found, but findings for artificially sweetened beverages were likely affected by publication bias and residual confounding; for fruit juice, the positive association was not stable and sensitive to study design.
“Under assumption of causality for the association of consumption of sugar-sweetened beverages with incident type 2 diabetes, we provided efficacy estimates that over 10 years two million type 2 diabetes events in the U.S. and 80,000 in the U.K. would be related to consumption of sugar-sweetened beverages,” according to Dr. Fumiaki Imamura of the University of Cambridge School of Clinical Medicine, and his colleagues.
“Future work should seek to improve precision of evidence and characterize efficacy and effectiveness of policy interventions for different populations,” according to the researchers.
Read the full study in the BMJ (doi:10.1136/bmj.h3576).
Drinking sugar-sweetened beverages is associated with a greater incidence of type 2 diabetes, independent of obesity, according to a systematic review and meta-analysis.
The researchers analyzed data from prospective design studies that assessed the consumption of beverages and incident type 2 diabetes, recruited adults free of diabetes, and followed study participants for at least 2 years. The data came from 17 cohorts comprising 38,253 cases of type 2 diabetes over 10,126,756 person-years. Using risk estimates, sampling weights, and population size, the researchers estimated the absolute number of incidents of type 2 diabetes over 10 years, the number of incidents of type 2 diabetes attributable to consumption of sugar-sweetened beverages, and the proportion of the disease incidents attributable to drinking of sugar-sweetened beverages. These estimations assumed causality and no change in individuals’ characteristics over time.
Higher consumption of sugar-sweetened beverages by one serving per day was associated with an 18% greater incidence of type 2 diabetes (95% confidence interval, 8.8%-28%; I2 [for heterogeneity] = 89%), before adjustment for adiposity. When adjusted for potential mediation and confounding by adiposity, the association was weakened to a 13% greater incidence of the disease.
Associations between drinking of artificially sweetened beverages and fruit juice were also found, but findings for artificially sweetened beverages were likely affected by publication bias and residual confounding; for fruit juice, the positive association was not stable and sensitive to study design.
“Under assumption of causality for the association of consumption of sugar-sweetened beverages with incident type 2 diabetes, we provided efficacy estimates that over 10 years two million type 2 diabetes events in the U.S. and 80,000 in the U.K. would be related to consumption of sugar-sweetened beverages,” according to Dr. Fumiaki Imamura of the University of Cambridge School of Clinical Medicine, and his colleagues.
“Future work should seek to improve precision of evidence and characterize efficacy and effectiveness of policy interventions for different populations,” according to the researchers.
Read the full study in the BMJ (doi:10.1136/bmj.h3576).
FROM THE BMJ
Moderate THST was most effective at treating thyroid cancer
Moderate thyroid hormone suppression therapy (THST) is associated with the best outcomes for patients with all stages of thyroid cancer, according to a prospective analysis of a multi-institutional registry published in the Journal of Clinical Endocrinology & Metabolism.
The researchers examined the outcomes of initial treatment for 4,941 patients with differentiated thyroid cancer (DTC), according to registry data from the National Thyroid Cancer Treatment Cooperative Study Group. The treatments included total/near total thyroidectomy (T/NTT), postoperative radioactive iodine-131 (131I), and THST. The median duration between treatment and follow-up for a patient was 6 years, with follow-up information available for all but 94 (1.9%) of the patients in the cohort.
Overall improvement was noted in stage III patients who received 131I (risk ratio, 0.66; P = .04) and stage IV patients who received both T/NTT and 131I (RR, 0.66; P = .049). In all stages, moderate THST was associated with significantly improved overall survival (RR stages I-IV: 0.13, 0.09, 0.13, and 0.33, respectively) and disease-free survival (DFS) (RR stages I-III: 0.52, 0.40, and 0.18, respectively); no additional survival benefit was achieved with more aggressive THST, even when distant metastatic disease was diagnosed during follow-up.
Lower initial stage and moderate THST were independent predictors of improved overall survival during follow-up years 1-3.
Consistent with previous research, this study also showed that T/NTT followed by 131I is associated with benefit in high-risk, but not low-risk patients.
“We report for the first time, in multivariate analysis of primary treatments for DTC, across all stages, only THST was associated with both improved stage-adjusted OS and DFS,” noted Dr. Aubrey A. Carhill and his colleagues.
“This analysis of the larger, more mature registry database extends and refines earlier observations regarding the impact of initial therapies on patient outcomes and further justifies the need for prospective, long-term, controlled studies,” the researchers noted.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2015-1346).
Moderate thyroid hormone suppression therapy (THST) is associated with the best outcomes for patients with all stages of thyroid cancer, according to a prospective analysis of a multi-institutional registry published in the Journal of Clinical Endocrinology & Metabolism.
The researchers examined the outcomes of initial treatment for 4,941 patients with differentiated thyroid cancer (DTC), according to registry data from the National Thyroid Cancer Treatment Cooperative Study Group. The treatments included total/near total thyroidectomy (T/NTT), postoperative radioactive iodine-131 (131I), and THST. The median duration between treatment and follow-up for a patient was 6 years, with follow-up information available for all but 94 (1.9%) of the patients in the cohort.
Overall improvement was noted in stage III patients who received 131I (risk ratio, 0.66; P = .04) and stage IV patients who received both T/NTT and 131I (RR, 0.66; P = .049). In all stages, moderate THST was associated with significantly improved overall survival (RR stages I-IV: 0.13, 0.09, 0.13, and 0.33, respectively) and disease-free survival (DFS) (RR stages I-III: 0.52, 0.40, and 0.18, respectively); no additional survival benefit was achieved with more aggressive THST, even when distant metastatic disease was diagnosed during follow-up.
Lower initial stage and moderate THST were independent predictors of improved overall survival during follow-up years 1-3.
Consistent with previous research, this study also showed that T/NTT followed by 131I is associated with benefit in high-risk, but not low-risk patients.
“We report for the first time, in multivariate analysis of primary treatments for DTC, across all stages, only THST was associated with both improved stage-adjusted OS and DFS,” noted Dr. Aubrey A. Carhill and his colleagues.
“This analysis of the larger, more mature registry database extends and refines earlier observations regarding the impact of initial therapies on patient outcomes and further justifies the need for prospective, long-term, controlled studies,” the researchers noted.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2015-1346).
Moderate thyroid hormone suppression therapy (THST) is associated with the best outcomes for patients with all stages of thyroid cancer, according to a prospective analysis of a multi-institutional registry published in the Journal of Clinical Endocrinology & Metabolism.
The researchers examined the outcomes of initial treatment for 4,941 patients with differentiated thyroid cancer (DTC), according to registry data from the National Thyroid Cancer Treatment Cooperative Study Group. The treatments included total/near total thyroidectomy (T/NTT), postoperative radioactive iodine-131 (131I), and THST. The median duration between treatment and follow-up for a patient was 6 years, with follow-up information available for all but 94 (1.9%) of the patients in the cohort.
Overall improvement was noted in stage III patients who received 131I (risk ratio, 0.66; P = .04) and stage IV patients who received both T/NTT and 131I (RR, 0.66; P = .049). In all stages, moderate THST was associated with significantly improved overall survival (RR stages I-IV: 0.13, 0.09, 0.13, and 0.33, respectively) and disease-free survival (DFS) (RR stages I-III: 0.52, 0.40, and 0.18, respectively); no additional survival benefit was achieved with more aggressive THST, even when distant metastatic disease was diagnosed during follow-up.
Lower initial stage and moderate THST were independent predictors of improved overall survival during follow-up years 1-3.
Consistent with previous research, this study also showed that T/NTT followed by 131I is associated with benefit in high-risk, but not low-risk patients.
“We report for the first time, in multivariate analysis of primary treatments for DTC, across all stages, only THST was associated with both improved stage-adjusted OS and DFS,” noted Dr. Aubrey A. Carhill and his colleagues.
“This analysis of the larger, more mature registry database extends and refines earlier observations regarding the impact of initial therapies on patient outcomes and further justifies the need for prospective, long-term, controlled studies,” the researchers noted.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2015-1346).
Corpus callosum functioning, structural integrity impaired in some TBI patients
Half of moderate to severe traumatic brain injury patients had markedly impaired corpus callosum (CC) functioning and structural integrity that is associated with poor neurocognitive functioning, according to a study of children aged 8-19 years.
The researchers used high angular resolution diffusion-weighted imaging to determine the structural integrities of the CC in 32 children who had suffered a traumatic brain injury (TBI) and of the CC in 31 healthy children. Patients in the experimental group had suffered from a moderate to severe TBI 1-5 months prior to the study. The researchers assessed CC function through interhemispheric transfer time (IHTT) – the time required to transfer stimulus-locked neural activity between the left and right brain hemispheres. Each participant’s IHTT was calculated from recording electroencephalography, while he or she completed a computerized, pattern-matching task with bilateral field advantage.
Half of the TBI patients had significantly slower IHTTs than did the control group. The IHTTs of this so-called IHTT-slow TBI group deviated by at least 1.5 standard deviations from data for the healthy control group.
The IHTT-slow TBI group also demonstrated lower CC integrity and poorer neurocognitive functioning than did both the control group and the remaining members of the experimental group. Lower fractional anisotropy (FA) – a common sign of impaired white matter (WM) – and slower IHTTs also predicted poor neurocognitive function.
“When we compared the IHTT-slow TBI group to the healthy control group, we found significant differences in callosal WM integrity, as well as the integrity of the association and projection tract systems tested. Lower FA and higher mean diffusivity (MD) in the IHTT-slow group suggests myelin disruption,” noted Emily L Dennis of the University of Southern California, Marina del Rey, and her colleagues. “When we compared the IHTT-normal TBI group to the healthy control group, we found only a few areas where the TBI group had significantly lower FA and no significant differences in MD [mean diffusivity].”
Read the full study in the Journal of Neuroscience (doi:10.1523/JNEUROSCI.1595-15.2015).
Half of moderate to severe traumatic brain injury patients had markedly impaired corpus callosum (CC) functioning and structural integrity that is associated with poor neurocognitive functioning, according to a study of children aged 8-19 years.
The researchers used high angular resolution diffusion-weighted imaging to determine the structural integrities of the CC in 32 children who had suffered a traumatic brain injury (TBI) and of the CC in 31 healthy children. Patients in the experimental group had suffered from a moderate to severe TBI 1-5 months prior to the study. The researchers assessed CC function through interhemispheric transfer time (IHTT) – the time required to transfer stimulus-locked neural activity between the left and right brain hemispheres. Each participant’s IHTT was calculated from recording electroencephalography, while he or she completed a computerized, pattern-matching task with bilateral field advantage.
Half of the TBI patients had significantly slower IHTTs than did the control group. The IHTTs of this so-called IHTT-slow TBI group deviated by at least 1.5 standard deviations from data for the healthy control group.
The IHTT-slow TBI group also demonstrated lower CC integrity and poorer neurocognitive functioning than did both the control group and the remaining members of the experimental group. Lower fractional anisotropy (FA) – a common sign of impaired white matter (WM) – and slower IHTTs also predicted poor neurocognitive function.
“When we compared the IHTT-slow TBI group to the healthy control group, we found significant differences in callosal WM integrity, as well as the integrity of the association and projection tract systems tested. Lower FA and higher mean diffusivity (MD) in the IHTT-slow group suggests myelin disruption,” noted Emily L Dennis of the University of Southern California, Marina del Rey, and her colleagues. “When we compared the IHTT-normal TBI group to the healthy control group, we found only a few areas where the TBI group had significantly lower FA and no significant differences in MD [mean diffusivity].”
Read the full study in the Journal of Neuroscience (doi:10.1523/JNEUROSCI.1595-15.2015).
Half of moderate to severe traumatic brain injury patients had markedly impaired corpus callosum (CC) functioning and structural integrity that is associated with poor neurocognitive functioning, according to a study of children aged 8-19 years.
The researchers used high angular resolution diffusion-weighted imaging to determine the structural integrities of the CC in 32 children who had suffered a traumatic brain injury (TBI) and of the CC in 31 healthy children. Patients in the experimental group had suffered from a moderate to severe TBI 1-5 months prior to the study. The researchers assessed CC function through interhemispheric transfer time (IHTT) – the time required to transfer stimulus-locked neural activity between the left and right brain hemispheres. Each participant’s IHTT was calculated from recording electroencephalography, while he or she completed a computerized, pattern-matching task with bilateral field advantage.
Half of the TBI patients had significantly slower IHTTs than did the control group. The IHTTs of this so-called IHTT-slow TBI group deviated by at least 1.5 standard deviations from data for the healthy control group.
The IHTT-slow TBI group also demonstrated lower CC integrity and poorer neurocognitive functioning than did both the control group and the remaining members of the experimental group. Lower fractional anisotropy (FA) – a common sign of impaired white matter (WM) – and slower IHTTs also predicted poor neurocognitive function.
“When we compared the IHTT-slow TBI group to the healthy control group, we found significant differences in callosal WM integrity, as well as the integrity of the association and projection tract systems tested. Lower FA and higher mean diffusivity (MD) in the IHTT-slow group suggests myelin disruption,” noted Emily L Dennis of the University of Southern California, Marina del Rey, and her colleagues. “When we compared the IHTT-normal TBI group to the healthy control group, we found only a few areas where the TBI group had significantly lower FA and no significant differences in MD [mean diffusivity].”
Read the full study in the Journal of Neuroscience (doi:10.1523/JNEUROSCI.1595-15.2015).
FROM THE JOURNAL OF NEUROSCIENCE
Patients’ web portals to access EHRs need improvement
Owners and creators of patient-facing web portals to access individuals’ electronic health records (EHRs) need to improve the portals’ usability, according to researchers from the University of California San Francisco.
The essay is a response to the efficacy of the federal Meaningful Use program, a multibillion-dollar EHR incentive program managed by the Office of the National Coordinator for Health Information Technology.
So far, the federal government has awarded more than $25 billion to health care clinics and hospitals to “incentivize [them] to implement electronic health records across the United States,” Courtney Lyles, Ph.D., and her colleagues said in a statement. The program covers a number of targets, including patient registration and use of portal websites that are linked to patients’ electronic health records.
The authors acknowledged the program’s success at awarding payments for EHR implementation; 94% of U.S. hospitals and 77% of U.S. office-based health professionals have received implementation payments. But the authors complained that “the lack of usability [of the web portals] is a formidable barrier to achieving widespread use of portals and other patient-facing technology, particularity for diverse groups.”
A study of a racially and ethnically diverse group of 51 older adults, which the authors cited in the essay, suggests that their criticism of the portals is warranted.
According to the study, only 12% of participants who said they would use a portal website after being shown a video were able to correctly complete a set of simple tasks – and none was able to complete a set of complex tasks with the portal (J. Appl. Gerontol. 2014;33:416-36).
The essay’s authors also expressed concern about the challenges faced specifically by non-English speakers and those with limited literacy.
Health care providers and hospital systems should “look to purchase EHRs with patient-facing portal products that meet the basic needs of their population,” the authors suggested. For example, such products should be accessible in the languages best understood by health systems’ patients. The authors also urged EHR/portal programmers and developers to “familiarize themselves with the issues of health literacy and health care disparities.”
Read the full essay in PLoS Medicine (July 14, 2015 [doi:10.1371/journal.pmed.1001852]).
Owners and creators of patient-facing web portals to access individuals’ electronic health records (EHRs) need to improve the portals’ usability, according to researchers from the University of California San Francisco.
The essay is a response to the efficacy of the federal Meaningful Use program, a multibillion-dollar EHR incentive program managed by the Office of the National Coordinator for Health Information Technology.
So far, the federal government has awarded more than $25 billion to health care clinics and hospitals to “incentivize [them] to implement electronic health records across the United States,” Courtney Lyles, Ph.D., and her colleagues said in a statement. The program covers a number of targets, including patient registration and use of portal websites that are linked to patients’ electronic health records.
The authors acknowledged the program’s success at awarding payments for EHR implementation; 94% of U.S. hospitals and 77% of U.S. office-based health professionals have received implementation payments. But the authors complained that “the lack of usability [of the web portals] is a formidable barrier to achieving widespread use of portals and other patient-facing technology, particularity for diverse groups.”
A study of a racially and ethnically diverse group of 51 older adults, which the authors cited in the essay, suggests that their criticism of the portals is warranted.
According to the study, only 12% of participants who said they would use a portal website after being shown a video were able to correctly complete a set of simple tasks – and none was able to complete a set of complex tasks with the portal (J. Appl. Gerontol. 2014;33:416-36).
The essay’s authors also expressed concern about the challenges faced specifically by non-English speakers and those with limited literacy.
Health care providers and hospital systems should “look to purchase EHRs with patient-facing portal products that meet the basic needs of their population,” the authors suggested. For example, such products should be accessible in the languages best understood by health systems’ patients. The authors also urged EHR/portal programmers and developers to “familiarize themselves with the issues of health literacy and health care disparities.”
Read the full essay in PLoS Medicine (July 14, 2015 [doi:10.1371/journal.pmed.1001852]).
Owners and creators of patient-facing web portals to access individuals’ electronic health records (EHRs) need to improve the portals’ usability, according to researchers from the University of California San Francisco.
The essay is a response to the efficacy of the federal Meaningful Use program, a multibillion-dollar EHR incentive program managed by the Office of the National Coordinator for Health Information Technology.
So far, the federal government has awarded more than $25 billion to health care clinics and hospitals to “incentivize [them] to implement electronic health records across the United States,” Courtney Lyles, Ph.D., and her colleagues said in a statement. The program covers a number of targets, including patient registration and use of portal websites that are linked to patients’ electronic health records.
The authors acknowledged the program’s success at awarding payments for EHR implementation; 94% of U.S. hospitals and 77% of U.S. office-based health professionals have received implementation payments. But the authors complained that “the lack of usability [of the web portals] is a formidable barrier to achieving widespread use of portals and other patient-facing technology, particularity for diverse groups.”
A study of a racially and ethnically diverse group of 51 older adults, which the authors cited in the essay, suggests that their criticism of the portals is warranted.
According to the study, only 12% of participants who said they would use a portal website after being shown a video were able to correctly complete a set of simple tasks – and none was able to complete a set of complex tasks with the portal (J. Appl. Gerontol. 2014;33:416-36).
The essay’s authors also expressed concern about the challenges faced specifically by non-English speakers and those with limited literacy.
Health care providers and hospital systems should “look to purchase EHRs with patient-facing portal products that meet the basic needs of their population,” the authors suggested. For example, such products should be accessible in the languages best understood by health systems’ patients. The authors also urged EHR/portal programmers and developers to “familiarize themselves with the issues of health literacy and health care disparities.”
Read the full essay in PLoS Medicine (July 14, 2015 [doi:10.1371/journal.pmed.1001852]).
FROM PLOS MEDICINE
Higher cardiorespiratory fitness linked with less depression in middle schoolers
Improving cardiorespiratory fitness may help prevent depression in adolescents, according to a study of 197 male and 240 female middle schoolers in Texas.
The study participants’ weight, height, physical fitness, and psychological well-being were assessed twice, once during sixth grade and once during seventh grade.
The sixth grade assessments showed strong cross-sectional associations between cardiorespiratory fitness (CRF) and less depression for both the male and female groups.
Examining the data for the girls alone showed more evidence of higher CRF being negatively correlated with depression, in that the girls’ sixth grade CRF was determined to be “a significant predictor of lower depression in seventh grade,” after sixth grade body composition and depression were controlled for. Data for the boys showed this trend as well, but this finding was not statistically significant.
A significant finding from studying the male subset was that sixth grade depression was a predictor of poorer CRF in seventh grade.
“Preexisting levels of depression (i.e., in sixth grade) were the most powerful predictor of subsequent depression. However, even after controlling for sixth grade depression and body composition, higher levels of CRF in sixth grade were associated with significantly less depression by the seventh grade for girls,” according to Camilo J. Ruggero, Ph.D., of the University of North Texas, Denton, and his colleagues.
“Moving forward, stakeholders and researchers concerned about depression during middle school would benefit from regular assessment of not simply physical activity, but levels of CRF as well,” noted the researchers.
Read the full study in the Journal of Adolescent Health.
Improving cardiorespiratory fitness may help prevent depression in adolescents, according to a study of 197 male and 240 female middle schoolers in Texas.
The study participants’ weight, height, physical fitness, and psychological well-being were assessed twice, once during sixth grade and once during seventh grade.
The sixth grade assessments showed strong cross-sectional associations between cardiorespiratory fitness (CRF) and less depression for both the male and female groups.
Examining the data for the girls alone showed more evidence of higher CRF being negatively correlated with depression, in that the girls’ sixth grade CRF was determined to be “a significant predictor of lower depression in seventh grade,” after sixth grade body composition and depression were controlled for. Data for the boys showed this trend as well, but this finding was not statistically significant.
A significant finding from studying the male subset was that sixth grade depression was a predictor of poorer CRF in seventh grade.
“Preexisting levels of depression (i.e., in sixth grade) were the most powerful predictor of subsequent depression. However, even after controlling for sixth grade depression and body composition, higher levels of CRF in sixth grade were associated with significantly less depression by the seventh grade for girls,” according to Camilo J. Ruggero, Ph.D., of the University of North Texas, Denton, and his colleagues.
“Moving forward, stakeholders and researchers concerned about depression during middle school would benefit from regular assessment of not simply physical activity, but levels of CRF as well,” noted the researchers.
Read the full study in the Journal of Adolescent Health.
Improving cardiorespiratory fitness may help prevent depression in adolescents, according to a study of 197 male and 240 female middle schoolers in Texas.
The study participants’ weight, height, physical fitness, and psychological well-being were assessed twice, once during sixth grade and once during seventh grade.
The sixth grade assessments showed strong cross-sectional associations between cardiorespiratory fitness (CRF) and less depression for both the male and female groups.
Examining the data for the girls alone showed more evidence of higher CRF being negatively correlated with depression, in that the girls’ sixth grade CRF was determined to be “a significant predictor of lower depression in seventh grade,” after sixth grade body composition and depression were controlled for. Data for the boys showed this trend as well, but this finding was not statistically significant.
A significant finding from studying the male subset was that sixth grade depression was a predictor of poorer CRF in seventh grade.
“Preexisting levels of depression (i.e., in sixth grade) were the most powerful predictor of subsequent depression. However, even after controlling for sixth grade depression and body composition, higher levels of CRF in sixth grade were associated with significantly less depression by the seventh grade for girls,” according to Camilo J. Ruggero, Ph.D., of the University of North Texas, Denton, and his colleagues.
“Moving forward, stakeholders and researchers concerned about depression during middle school would benefit from regular assessment of not simply physical activity, but levels of CRF as well,” noted the researchers.
Read the full study in the Journal of Adolescent Health.
FROM JOURNAL OF ADOLESCENT HEALTH
RAI given to thyroid CA patients does not increase their breast malignancy occurrence, recurrence
Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.
The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.
The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.
“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).
This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.
Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.
The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.
The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.
“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).
This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.
Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.
The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.
The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.
“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).
This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Oral cholera vaccine reduced incidence of disease
An oral cholera vaccine was effective at reducing the incidence of severely dehydrating cholera and patient presentations of life-threatening cholera according to a cluster-randomized, open-label trial of residents of an urban endemic setting in Bangladesh.
The study’s participants were divided into 90 clusters of individuals targeted as being at high risk for contracting cholera. Patients in one-third of the clusters were offered Shanchol (Shantha Biotechnics–Sanofi ) vaccines. Patients in another third of the clusters were offered the Shanchol vaccine plus instructions and tools for improving hygiene. Patients in the final third of the clusters were not offered either intervention. Government services administered the vaccine as two doses at an interval of at least 14 days. Of the 94,675 patients in the vaccination-only clusters, 65% got vaccinated. Similarly, 66% of the 92,539 patients in the vaccination plus hygienic improvements clusters received vaccinations.
Overall, the vaccine’s effectiveness at protecting against cholera was 37% in the vaccination group and 45% in the vaccination plus hygienic improvements group.
“Our findings show that a routine oral cholera vaccination program in cholera-endemic countries could substantially reduce the burden of disease and greatly contribute to cholera control effects,” said lead author Dr. Firdausi Qadri of the International Centre for Diarrhoeal Disease Research, Bangladesh, in a statement.
The research was funded by the Bill & Melinda Gates Foundation.
Read the full study in the Lancet.
*This story was updated 7/9/2015.
An oral cholera vaccine was effective at reducing the incidence of severely dehydrating cholera and patient presentations of life-threatening cholera according to a cluster-randomized, open-label trial of residents of an urban endemic setting in Bangladesh.
The study’s participants were divided into 90 clusters of individuals targeted as being at high risk for contracting cholera. Patients in one-third of the clusters were offered Shanchol (Shantha Biotechnics–Sanofi ) vaccines. Patients in another third of the clusters were offered the Shanchol vaccine plus instructions and tools for improving hygiene. Patients in the final third of the clusters were not offered either intervention. Government services administered the vaccine as two doses at an interval of at least 14 days. Of the 94,675 patients in the vaccination-only clusters, 65% got vaccinated. Similarly, 66% of the 92,539 patients in the vaccination plus hygienic improvements clusters received vaccinations.
Overall, the vaccine’s effectiveness at protecting against cholera was 37% in the vaccination group and 45% in the vaccination plus hygienic improvements group.
“Our findings show that a routine oral cholera vaccination program in cholera-endemic countries could substantially reduce the burden of disease and greatly contribute to cholera control effects,” said lead author Dr. Firdausi Qadri of the International Centre for Diarrhoeal Disease Research, Bangladesh, in a statement.
The research was funded by the Bill & Melinda Gates Foundation.
Read the full study in the Lancet.
*This story was updated 7/9/2015.
An oral cholera vaccine was effective at reducing the incidence of severely dehydrating cholera and patient presentations of life-threatening cholera according to a cluster-randomized, open-label trial of residents of an urban endemic setting in Bangladesh.
The study’s participants were divided into 90 clusters of individuals targeted as being at high risk for contracting cholera. Patients in one-third of the clusters were offered Shanchol (Shantha Biotechnics–Sanofi ) vaccines. Patients in another third of the clusters were offered the Shanchol vaccine plus instructions and tools for improving hygiene. Patients in the final third of the clusters were not offered either intervention. Government services administered the vaccine as two doses at an interval of at least 14 days. Of the 94,675 patients in the vaccination-only clusters, 65% got vaccinated. Similarly, 66% of the 92,539 patients in the vaccination plus hygienic improvements clusters received vaccinations.
Overall, the vaccine’s effectiveness at protecting against cholera was 37% in the vaccination group and 45% in the vaccination plus hygienic improvements group.
“Our findings show that a routine oral cholera vaccination program in cholera-endemic countries could substantially reduce the burden of disease and greatly contribute to cholera control effects,” said lead author Dr. Firdausi Qadri of the International Centre for Diarrhoeal Disease Research, Bangladesh, in a statement.
The research was funded by the Bill & Melinda Gates Foundation.
Read the full study in the Lancet.
*This story was updated 7/9/2015.
FROM THE LANCET
FDA probes safety of codeine-containing medicine in children
The Food and Drug Administration wants health care professionals and patients to report adverse events or side effects stemming from codeine-containing medicine use in people under age 18 years to assist it with a new investigation.
The agency is trying to determine if it is safe for people under 18 years of age to treat coughs and colds with codeine-containing medicines, according to a statement released today. These drugs’ potential for causing slowed or difficult breathing was the impetus for the investigation.
The investigation follows the European Medicine Agency’s announcement, in April 2015, that codeine must not be used to treat cough and cold in children under 12 years, and that codeine use is not recommended for people between the ages of 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems. In 2013, the FDA issued a statement warning of the risks of codeine use by children who had recently had surgery to remove their tonsils and/or adenoids.
The FDA “will consider the EMA recommendations” and announce its final conclusions and recommendations after it completes the investigation, said the agency in its recent statement.
Reports on problems with codeine-containing medicines can be submitted online at www.fda.gov.MedWatch/report, by fax (1-800-FDA-0178), or by mail. The FDA’s official reporting forms can be obtained by download or by calling 1-800-332-1088 to request a form.
The Food and Drug Administration wants health care professionals and patients to report adverse events or side effects stemming from codeine-containing medicine use in people under age 18 years to assist it with a new investigation.
The agency is trying to determine if it is safe for people under 18 years of age to treat coughs and colds with codeine-containing medicines, according to a statement released today. These drugs’ potential for causing slowed or difficult breathing was the impetus for the investigation.
The investigation follows the European Medicine Agency’s announcement, in April 2015, that codeine must not be used to treat cough and cold in children under 12 years, and that codeine use is not recommended for people between the ages of 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems. In 2013, the FDA issued a statement warning of the risks of codeine use by children who had recently had surgery to remove their tonsils and/or adenoids.
The FDA “will consider the EMA recommendations” and announce its final conclusions and recommendations after it completes the investigation, said the agency in its recent statement.
Reports on problems with codeine-containing medicines can be submitted online at www.fda.gov.MedWatch/report, by fax (1-800-FDA-0178), or by mail. The FDA’s official reporting forms can be obtained by download or by calling 1-800-332-1088 to request a form.
The Food and Drug Administration wants health care professionals and patients to report adverse events or side effects stemming from codeine-containing medicine use in people under age 18 years to assist it with a new investigation.
The agency is trying to determine if it is safe for people under 18 years of age to treat coughs and colds with codeine-containing medicines, according to a statement released today. These drugs’ potential for causing slowed or difficult breathing was the impetus for the investigation.
The investigation follows the European Medicine Agency’s announcement, in April 2015, that codeine must not be used to treat cough and cold in children under 12 years, and that codeine use is not recommended for people between the ages of 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems. In 2013, the FDA issued a statement warning of the risks of codeine use by children who had recently had surgery to remove their tonsils and/or adenoids.
The FDA “will consider the EMA recommendations” and announce its final conclusions and recommendations after it completes the investigation, said the agency in its recent statement.
Reports on problems with codeine-containing medicines can be submitted online at www.fda.gov.MedWatch/report, by fax (1-800-FDA-0178), or by mail. The FDA’s official reporting forms can be obtained by download or by calling 1-800-332-1088 to request a form.