Tysabri / Natalizumab

Modified on 2009/10/14 21:48 by admin
FDA issued a 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 received reports of one confirmed, fatal case and one possible case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for multiple sclerosis. 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 announced 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.

In March 2005, Biogen & Elan Pharmaceuticals reported that an investigation into the safety of Tysabri uncovered a second patient death linked to the drug. The death occurred in 2003 and was reportedly misdiagnosed as brain cancer.

See your doctor if you have experienced serious side effects associated with Tysabri. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

*Source: Food and Drug Administration

See Also

  1. Multiple Sclerosis Drugs
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