Due to 31 confirmed cases of progressive multifocal leukoencephalopathy (PML) reported through January 21, 2010, the FDA has issued a notification to healthcare professionals and patients concerning the increased risks of developing PML with the number of Tysabri infusions received.
The increased risk of developing PML will now be included in the drug label and Patient Medication Guide. According to the FDA, the possibility of developing Immune Reconstitution Inflammatory Syndrome (IRIS) in patients who have developed PML and subsequently discontinued Tysabri has been added to the label as well. The FDA describes IRIS is a rare condition that causes a severe inflammatory response during or following immune system recovery, which can in turn cause a decline in patient condition following the return of immune system function.
For the complete MedWatch update, please see FDA/Tysabri. To report a suspected drug side effect to the FDA’s MedWatch Adverse Event Reporting Program see www.fda.gov/MedWatch/report.htm, or phone 800-FDA-1088.
The Law Firm of Eric H. Weinberg represents victims of pharmaceutical drug products nationwide. We are ready to help you. If you or a loved one has been injured as a result of Tysabri or another drug product and you have a question concerning your legal rights, please call us toll free at 1-877-934-6274, or see Drug Recall Lawyer.
To learn about our recent pharmaceutical litigation efforts, please see Yaz and Yasmin Lawsuit, Reglan Lawsuit, and Levaquin Lawsuit.
