Possible fifth Tysabri-related case - WSJ

A possible fifth case of a rare and often fatal brain infection linked to the multiple sclerosis drug Tysabri has been reported to federal regulators, the Wall Street Journal reported on Monday.

The case was reported on May 16 through the Food and Drug Administration’s Adverse Event Reporting System, which collects reports of possible drug reactions from physicians and drug makers. An FDA spokeswoman told the Journal that these reports do not represent confirmed cases.

The drug’s makers, Biogen Idec Inc. and Elan Corp. Plc, have reported three confirmed cases of progressive multifocal leukoencephalopathy in patients taking Tysabri. Two of the patients died, while the third is reported to have shown recent improvement. The companies stopped selling the drug in February.

A possible fourth case was reported to the FDA earlier this month, but the companies said the PML diagnosis has not been confirmed. The fifth possible case concerns a female patient, of an undisclosed age, who has been hospitalized. No other details of her condition are available.

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