-- Scott Roberts
MONDAY, March 31, 2014 (HealthDay News) -- 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
The FDA has more about
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