Resources for Food and Drug Administration (FDA)

Sabril: An Epilepsy Drug’s 15-Year FDA Odyssey

blogs.wsj.com

It was the mid-90s when the epilepsy drug Sabril first came before the FDA, and it’s not done yet. The latest twist came this week, when an FDA advisory committee voted unanimously to recommend approval of the drug for two uses: infantile spasms, and complex partial seizures in adults.Sabril carries a pretty serious side effect: A substantial minority of patients — about 25% of adults — suffer irreversible damage to their peripheral vision. What’s more, MRIs of patients’ brains have shown abnormalities in some cases, but there haven’t been reports of clincial problems associated with the abnormalities Tim Cunniff told the Health Blog. Cunniff is a VP at Ovation Pharmaceuticals, which owns rights to the drug in the U.S.

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