Topamax Approval for Migraines Expanded to Younger Users
MONDAY, March 31, 2014 -- U.S. Food and Drug Administration approval of the drug Topamax (topiramate) to prevent migraine headaches has been expanded to include adolescents 12 years to 17 years, the agency said Friday.
It's the first migraine-prevention drug approved for adolescents, the FDA said in a news release. Topamax was first sanctioned in 1996 to prevent seizures, and was approved to prevent migraines in adults in 2004.
Some 12 percent 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.
Topamax was evaluated in clinical studies involving 103 adolescent migraine sufferers. The most common side effects 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. Doctors should carefully consider this risk before prescribing Topamax to females of childbearing age, the agency said.
Topamax is produced by Janssen Pharmaceuticals, based in Titusville, N.J.
The FDA has more about this approval.
Posted: March 2014