HealthDay News — The FDA expanded the indication for topiramate (Topamax) for migraine prevention to include adolescents 12 years to 17 years, making it the first migraine-prevention drug approved for this population.
Topiramate was first sanctioned in 1996 to prevent seizures, and was approved to prevent migraines in adults in 2004. Some 12% of the U.S. population has migraines, usually characterized by throbbing pain on one side of the head. Other symptoms may include nausea and sensitivity to light and sound.
The drug was evaluated in clinical studies involving 103 adolescents ages 12 to 17 who experienced migraines.
Those treated with topiramate experienced a decrease in the frequency of migraine of approximately 72% compared with a 44% decrease in participants that took placebo.
The most common side effects for the approved 100 mg dose included burning or prickling sensations in the extremities, upper respiratory infection, loss of appetite and abdominal pain.
The drug increases the risk of cleft lip and cleft palate birth defects among infants born to pregnant users, the FDA said. Clinicians should carefully consider this risk before prescribing topiramate to women of childbearing age, the agency said.
Topiramate is produced by Janssen Pharmaceuticals in Titusville, N.J.