Topamax Approved for Adolescent Migraines, Same Oral Cleft Risks

The U.S. Food and Drug Administration (FDA) has approved Topamax (generic topiramate) for use in preventing migraine headaches in adolescents ages 12 to 17.

This is the first FDA approval of a migraine prevention drug for this age group. The medication is taken daily to reduce the frequency of migraine headaches.

Topamax was first approved by the FDA in 1996 to prevent seizures, and it was approved in 2004 for migraine prevention in adults, according to a press release by the FDA.

A clinical trial involving 103 participants established the safety and effectiveness of Topamax in preventing migraine headaches in the adolescent age group. Those treated with Topamax experienced fewer migraines of approximately 72 percent compared to 44 percent in participants who took a placebo.

The most common adverse reactions with the approved dose of Topamax were a burning or prickling sensation felt in the hands, arms, legs, or feet, upper respiratory infection, loss of appetite and abdominal pain. Topamax increases a person’s risk of suicidal thoughts and behavior, and patients should be on alert for symptoms of depression or unusual changes in mood or behavior.

Topamax also increases the risk of the development of cleft lip and palate in infants born to women who take the drug during pregnancy. The benefits of taking Topamax should be carefully weighed with these risks before women of childbearing age begin using it.

Effective birth control should be used if the decision is made to use Topamax by a woman of childbearing age, the press release says.

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