SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years. This is the first FDA approval of a drug for migraine prevention in this age group.
The medication is taken on a daily basis to reduce the frequency of migraine headaches.
Topamax was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.
“Migraine headaches can impact school performance, social interactions, and family life,” stated Eric Bastings, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “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.”
About 12% of the U.S. population experiences migraine headaches, the FDA noted.
Topamax is manufactured by Janssen Pharmaceuticals of Titusville, N.J.