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Seizure Warning Issued for MS Drug | cialis online

Seizure Warning Issued for MS Drug

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The U.S. Food & Drug Administration (FDA) just issued a seizure warning for multiple sclerosis (MS) drug, Ampyra (dalfampridine). Ampyra has been linked to increased seizure risks in MS patients.

Developed by Acorda Therapeutics, Ampyra is marketed by Biogen Idec Inc in Europe under the brand Fampyra, explained Reuters. The drug was created to improve walking ability in MS patients. Based on post-market adverse event reports it reviewed, said the agency, the seizure risk in MS patients—none of whom had a history of seizure—was evidenced within days and weeks after beginning treatment with the recommended dose, noted Reuters.

The FDA pointed out that seizures are a known risk linked to Ampyra, with the risk increasing with increased Ampyra blood levels, said Reuters. Ampyra is eliminated from the kidneys; therefore, those with kidney impairment may develop increased Ampyra blood levels, which, in turn, can lead to increased seizure risks, said the FDA. Specifically, said the agency, health care professionals should be aware of age-related renal function decreases; mild renal impairment is common after the age of 50.

Because of this, the agency is updating physician prescribing information to ensure the information clearly indicates that patient kidney function should be checked prior to Ampyra treatment and patients should continue to be monitored at least once yearly while on treatment, said Reuters. To avoid unnecessary seizure risk, should a dose be missed that dose should not be made, the FDA said.

Approved in the United States in January 2010, Biogen received conditional approval in Europe last July, said Reuters. Such conditional approval is granted when a drug’s benefits appear to outweigh its risks, but when additional information is needed to confirm this belief. In this case, as part of its approval conditions, regulators recommended that Biogen undergo an additional study to determine more about its long-term benefits and safety.

Ampyra should not be used in patients with a history of seizures or who have moderate to severe renal (kidney) impairment, which is measured as creatinine clearance [CrCl] that less than or equal to 50 mL/min, said the FDA. Ampyra should be discontinued permanently if a seizure occurs.

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