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FDA issues public health advisory for Tysabri

Pharmacy Regulation Resource, March 2, 2005

The FDA on February 28 issued a public health advisory to inform patients and healthcare providers about the suspended marketing of Tysabri (natalizumab) due to two serious adverse events reported with its use.

The 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, the FDA announced the following steps, effective immediately:

• Manufacturer 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

No specific diagnostic or therapeutic interventions are recommended for patients who have been taking Tysabri, other than to discontinue its use, the FDA said. Physicians should evaluate all patients who have received Tysabri and who have signs or symptoms suggestive of PML.

Healthcare providers should report any suspect cases of PML to Biogen Idec or to the FDA MedWatch program.

Read the notice and the public health advisory at www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Tysabri.

The advisory is the second one issued in less than a week. The FDA on February 22 notified healthcare professionals and the public that a bolded warning was added to the labeling for Gabitril (tiagabine), cautioning prescribers about the risk of seizures in patients without epilepsy who take the medication.

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