The FDA today announced the approval of topiramate for daily use in the prevention of migraines among adolescents aged 12 to 17 years.
Topiramate (Topamax, Janssen Pharmaceuticals) is the first drug to receive FDA approval to reduce the frequency of migraines in this age group. It received FDA approval for migraine prevention among adults in 2004, and was first approved to prevent seizures in 1996.
The approval was based in part on results of a trial that included 103 adolescents aged 12 to 17 years. Topiramate was associated with a 72% reduction in the frequency of migraines, compared with a 44% reduction observed among adolescents assigned placebo.
The most common adverse events observed with the 100-mg dose of topiramate were paresthesia, upper respiratory infection, anorexia and abdominal pain.
The FDA requires topiramate to be dispensed with a Medication Guide warning for the increased risk for suicidal thoughts and behavior associated with anti-epileptic agents. Topiramate also increases the risk for cleft lip and/or cleft palate among infants born to women taking the medication during pregnancy.
“Migraine headaches can impact school performance, social interactions and family life,” Eric Bastings, MD, deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”