Topiramate Approved for Migraine Prevention in Adolescents — Physician’s First Watch
Topiramate Approved for Migraine Prevention in Adolescents
By Amy Orciari Herman
The FDA has approved the antiepileptic topiramate (Topamax) to prevent migraine in adolescents aged 12 to 17, the agency announced on Friday. It's the first drug approved for migraine prevention in this age group.
Topiramate should be taken daily, at a dose of 100 mg. Its approval was based on a randomized trial of roughly 100 adolescents: those taking topiramate experienced a 72% decrease in migraine frequency, versus 44% among placebo recipients. Side effects included paresthesia, upper respiratory infection, loss of appetite, and abdominal pain.
Like all antiepileptic drugs, topiramate may increase the risk for suicidality. In addition, its use during pregnancy places infants at risk for oral clefts.
Topiramate has been approved to prevent seizures since 1996, and to prevent migraine in adults since 2004.