Tuesday, July 24, 2012

FDA warns of seizure risk in normal dosage of Dalfampridine.



MedPage Today (7/24, Phend) reports that the FDA issued a warning that "multiple sclerosis drug dalfampridine (Ampyra) can cause seizures in patients who are starting the medicine at normal doses," and "most seizures happened in patients with no history of seizures and occurred within days or weeks of starting the drug at its recommended dosage." The medication "was approved in 2010 to improve walking ability in MS." The FDA "pointed out that the drug is excreted renally, so kidney impairment may lead to higher blood levels that raise seizure risk."
        Reuters (7/24, Clarke) the medication, marketed as Fampyra in Europe, was known to have a seizure risk for dosages higher than that recommended. Now the FDA is recommending that kidney function be checked before prescribing the medication and checked at least annually thereafter. Also patients should not make up any missed doses as the extra dosage could increase the risk. 

No comments: