Quoted from http://www.reuters.com/article/2012/07/23/us-fda-ampyra-idUSBRE86M0W120120723
FDA warns about seizures with MS drug Ampyra
By Toni Clarke
WASHINGTON | Mon Jul 23, 2012 1:09pm EDT
WASHINGTON (Reuters) - The U.S. Food and Drug Administration has issued a warning to patients and physicians about the increased risk of seizures in multiple sclerosis patients taking the drug Ampyra.
The drug was developed by Acorda Therapeutics Inc to improve walking ability in patients with multiple sclerosis. Biogen Idec Inc has rights to the drug in Europe where it is sold under the brand name Fampyra.
The FDA said that based on reports, it recently evaluated seizure risk in MS patients taking Ampyra and noted that the majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients with no history of seizures.
Seizures are a known risk with Ampyra, the agency said, and the risk increases with higher blood levels of the drug. Since Ampyra is eliminated from the kidneys, patients with kidney impairment may develop higher blood levels of the drug, thus increasing their seizure risk, the FDA said.
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