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Topiramate has become the first drug to be approved for migraine prevention in adolescents, according to a release from the Food and Drug Administration.
First approved in 1996 to prevent seizures, topiramate (Topamax) was approved in 2004 for migraine prevention in adults. The new approval extends daily use of topiramate at 100 mg for migraine prophylaxis to adolescents as young as 12 years old.
"Adding dosing and safety information for the adolescent age group to the drug’s prescribing information will help to inform health care professionals and patients in making treatment choices," said Dr. Eric Bastings, deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
The approval was based on the results of a clinical trial of 103 adolescents aged 12-17 years. Those on topiramate had a 72% reduction in the frequency of migraines; those treated with placebo had a 44% reduction.
The most common adverse reactions with the approved dose were paresthesia, upper respiratory infection, anorexia, and abdominal pain.
Topiramate and all antiepileptic drugs may increase the risk of suicidal thoughts and behavior. Patients should be advised to be alert for the emergence or worsening of symptoms of depression and unusual changes in mood or behavior.
In women who take the drug during pregnancy, topiramate has been shown to increase the risk in offspring of cleft lip and palate. If the decision is made to use the medication by a woman of childbearing age, effective birth control should be used, the agency said in a release.
Topamax is manufactured by Janssen Pharmaceuticals.
On Twitter @maryjodales
Topiramate has become the first drug to be approved for migraine prevention in adolescents, according to a release from the Food and Drug Administration.
First approved in 1996 to prevent seizures, topiramate (Topamax) was approved in 2004 for migraine prevention in adults. The new approval extends daily use of topiramate at 100 mg for migraine prophylaxis to adolescents as young as 12 years old.
"Adding dosing and safety information for the adolescent age group to the drug’s prescribing information will help to inform health care professionals and patients in making treatment choices," said Dr. Eric Bastings, deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
The approval was based on the results of a clinical trial of 103 adolescents aged 12-17 years. Those on topiramate had a 72% reduction in the frequency of migraines; those treated with placebo had a 44% reduction.
The most common adverse reactions with the approved dose were paresthesia, upper respiratory infection, anorexia, and abdominal pain.
Topiramate and all antiepileptic drugs may increase the risk of suicidal thoughts and behavior. Patients should be advised to be alert for the emergence or worsening of symptoms of depression and unusual changes in mood or behavior.
In women who take the drug during pregnancy, topiramate has been shown to increase the risk in offspring of cleft lip and palate. If the decision is made to use the medication by a woman of childbearing age, effective birth control should be used, the agency said in a release.
Topamax is manufactured by Janssen Pharmaceuticals.
On Twitter @maryjodales
Topiramate has become the first drug to be approved for migraine prevention in adolescents, according to a release from the Food and Drug Administration.
First approved in 1996 to prevent seizures, topiramate (Topamax) was approved in 2004 for migraine prevention in adults. The new approval extends daily use of topiramate at 100 mg for migraine prophylaxis to adolescents as young as 12 years old.
"Adding dosing and safety information for the adolescent age group to the drug’s prescribing information will help to inform health care professionals and patients in making treatment choices," said Dr. Eric Bastings, deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
The approval was based on the results of a clinical trial of 103 adolescents aged 12-17 years. Those on topiramate had a 72% reduction in the frequency of migraines; those treated with placebo had a 44% reduction.
The most common adverse reactions with the approved dose were paresthesia, upper respiratory infection, anorexia, and abdominal pain.
Topiramate and all antiepileptic drugs may increase the risk of suicidal thoughts and behavior. Patients should be advised to be alert for the emergence or worsening of symptoms of depression and unusual changes in mood or behavior.
In women who take the drug during pregnancy, topiramate has been shown to increase the risk in offspring of cleft lip and palate. If the decision is made to use the medication by a woman of childbearing age, effective birth control should be used, the agency said in a release.
Topamax is manufactured by Janssen Pharmaceuticals.
On Twitter @maryjodales
