Dozens of multiple sclerosis (MS) patients urged the Food and Drug Administration (FDA) to return Tysabri to the market. The patients stated, in heartfelt testimonies, that the drug eased the strains of the disease.
Tysabri was pulled from the market in February 2005 after it was linked to a rare brain disorder known as progressive multifocal leukoencephalopathy (PML) that caused the known deaths of two patients. The head of neurology drug products for the FDA estimates that one out of every 1,000 patients treated with Tysabri will contract PML.
Biogen Idec Inc. and Elan Corp, the drug’s manufacturers, requested that the FDA allow Tysabri back on the market, with restrictions. They proposed a restricted-access program that would only make the drug available to registered patients, doctors and, in clinics, where the drug would be administered intravenously. They also proposed a “black-box” warning that would state the risk of PML and also detail that the drug should not be taken with any other MS drug. The FDA has until the end of March to determine the fate of Tysabri.
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