Migraine Prevention Drug Approved by FDA for Adolescents

March 31, 2014
Rachel Lutz

Clinical trial data show Topamax (topiramate) safely and effectively reduces the frequency of migraine in adolescents compared to placebo.

The US Food and Drug Administration (FDA) has approved Topamax (topiramate) for prophylaxis of migraine headache in adolescents age 12-17, making it the first drug approved in the US for this indication in this patient population.

In a trial with 103 patients, migraines decreased by about 72% in participants treated with 100 mg Topamax versus their placebo counterparts (44%).

“Migraine headaches can impact school performance, social interactions, and family life,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research in a statement. “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.”

The most common side effects with the approved dose of the drug were paresthesia, upper respiratory tract infection, anorexia, and abdominal pain. Topamax also increased the risk of development of cleft lip and/or cleft palate in infants born to women who took the drug during pregnancy. The FDA notes if women choose to use the drug during a childbearing age, effective birth control should be utilized. The FDA also warned Topamax and all antiepileptic drugs may increase the risk of suicidal thoughts and behavior, which should be monitored.