Resources for Food and Drug Administration (FDA)

FDA Wants Epilepsy Drugs To Carry Black-Box Warning

www.themedguru.com

With recent evidence showing high association between epilepsy drugs and risk of suicidal thoughts and behaviors, the U.S. Food and Drug Administration officials will seek to include the Black box warning, the strongest alert possible, for 11 such drugs, the agency announced on Monday.

In a meeting scheduled for Thursday, an advisory panel of outside medical experts appointed by the FDA will look into the suicidal behavior associated with epilepsy drugs and check if the benefits reaped from the drug usage surpass the allied risks.

Lamictal by GlaxoSmithKline, Pfizer Inc's Lyrica, Johnson & Johnson's Topamax, Cephalon Inc.'s Gabitril, Novartis AG's Trileptal and Abbott Laboratories Inc's Depakote are among the few top-selling epilepsy drugs that would require updating their labels for the warnings.

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