Tysabri (natalizumab) Marketing Suspended

FDA Public Health Advisory Suspended Marketing of Tysabri (natalizumab)

FDA is issuing this public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (natalizumab) due to two serious adverse events reported with its use. FDA has received a report from Biogen Idec, the manufacturer of Tysabri, of one confirmed, fatal case and one additional case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for multiple sclerosis (MS). Both patients were enrolled in a long-term clinical trial and had been taking Tysabri for more than two years. There have been no previous cases of PML reported in patients taking Tysabri.

Although the relationship between Tysabri and PML is not known at this time, because of the rare, serious and often fatal nature of PML, FDA is announcing the following, effective immediately:

Biogen Idec is voluntarily suspending marketing of Tysabri.

Biogen Idec is suspending dosing of Tysabri in clinical trials and is notifying patients and investigators of the possible association between Tysabri and PML.

Patients being treated with Tysabri should contact their physician to discuss appropriate alternative treatments. At this time, there are no specific diagnostic or therapeutic interventions recommended for patients who have been taking Tysabri, other than to discontinue its use. Physicians should evaluate all patients who have received Tysabri and who have signs or symptoms suggestive of PML. Any suspect cases of PML should be reported immediately to Biogen Idec or to the FDA MedWatch program, as described at the end of this advisory. FDA and Biogen Idec will provide further guidance should additional recommendations be deemed appropriate.

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