The U.S. Food and Drug Administration is working with Biogen Idec Inc. and Elan Corp. to fine-tune warnings about the risk of a potentially fatal virus infection of the brain, progressive multifocal leukoencephalopathy, in patients taking Tysabri for multiple sclerosis. A link to the disease was found in the past, leading to a temporary suspension of sales until pressure by patients willing to take the risk to obtain the benefits caused the drug to be returned to the market. Previous cases involved the use of Tysabri in combination with other drugs, all of which have immunosuppressive effects. The two new cases, both reported from Europe, affected patients receiving Tysabri alone. However, FDA noted that it believes the risk is lower in such patients. European regulators are considering what they should do.

In February 2005, 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 serious nature PML, the FDA deemed suspension of marketing appropriate. Biogen Idec is also 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.

If you or someone you know has been injured while taking Tysabri call our office today.  Our experienced team of attorneys will properly evaluate your case.  619.615.0767