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Topamex approved to manage migraines in teens

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Topomax (topiramate), first drug to treat migrainesfor kids12-17 FDA approval of a drug for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches.
Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches.

First approved by the FDA in 1996 to prevent seizures, Topamax (topiramate) has just been approved to treat migraines for kids 12 to 17. This is the first drug of its kind to be approved for use in adolescents by the agency.

It is now estimated that approximately 12% of people in the US population suffer from migraine headaches, which are characterized by episodes of throbbing and pulsating pain in the head, and often occur several times per month. Other common symptoms include increased sensitivity to light, noise, and odors, as well as nausea and vomiting. Many patients experience their first migraine attack before reaching adulthood, and can be just as disabling in teens as it is in adults.

“Migraine headaches can impact school performance, social interactions, and family life,” said Eric Bastings, M.D., 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.”

The most common side-effects reported during clinical trials using dosages of 100 mgs of Topamex were burning or prickling sensations in the hands, arms, legs, or feet), upper respiratory infection, loss of appetite, and abdominal pain.

However, due to the fact that Topamex is known to increase the risk of giving birth to babies with cleft lips and/or cleft palates if taken during pregnancy, the FDA emphasized that “the benefits and risks of prescribing the drug to any woman of child-bearing age should be carefully weighed beforehand, and that if the decision is made to use the medication by a woman of childbearing age, effective birth control should be used.”

Another warning is the fact that Topamex may also “carry a risk of suicidal thoughts and behavior.” As a result, patients (including adults) “need to worsening signs and symptoms of depression, or unusual changes in mood or behavior.”

For more information readers can contact the FDA at 888-INFO-FDA

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