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FDA Medwatch Alert: Ampyra (dalfampridine): Drug Safety Communication - Seizure Risk for Multiple Sclerosis Patients
Posted 23 Jul 2012 by Drugs.com
ISSUE: FDA is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine). The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures. The FDA is updating the Ampyra drug label to clarify recommendations. BACKGROUND: Ampyra was approved to improve walking in patients with MS. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug. Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk. R ... Read more