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Topiramate will only prevent migraine headaches or reduce the number of attacks.

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The chronic, disabling disease forces the heart to work harder than usual, and can lead to death or the need for a lung transplant, the FDA said in a news release.

Inform women of childbearing age of the increased risk for having a baby with an oral cleft if they become pregnant while using topiramate.

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The effectiveness of topiramate as an adjunctive treatment for pediatric patients ages 2 to 16 years with partial onset seizures was established in a multicenter, randomized, double-blind, placebo-controlled trial, comparing topiramate and placebo in patients with a history of partial onset seizures, with or without secondarily generalized seizures.

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