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FDA Approves Medication for Migraine Prevention in Teens

The U.S. Food and Drug Administration (FDA) recently approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 to 17.

Topiramate is the first drug to earn FDA approval for migraine prevention in this age group. Although it was prescribed for young migraineurs before the approval, this step is expected to provide benefits to physicians and patients.

“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. “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.”

A clinical trial of Topamax in 103 adolescent participants found that the frequency of migraine decreased approximately 72% in those who took the medication compared to 44% in participants who took a placebo.

The most common adverse reactions with the approved dose (100 milligrams) were paresthesia (abnormal skin sensations of burning, tingling, and prickling), upper respiratory infection, loss of appetite, and abdominal pain.

Many patients experience their initial migraine attack before reaching adulthood, and migraine can be just as disabling in teens as it is in adults.

Topamax was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.

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