New safety information will be included in the Tysabri (natalizumab) drug label and patient Medication Guide: The risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received.
PML is a rare brain infection that usually causes death or severe disability. This new safety information is based on reports of 31 confirmed cases of PML received by FDA as of Jan. 21, 2010.
The drug label will also include information about the occurrence of immune reconstitution inflammatory syndrome (IRIS) in people who developed PML and then stopped using Tysabri. IRIS is a rare but severe inflammatory response that can cause worsening of multiple sclerosis.
Tysabri is approved to treat relapsing forms of multiple sclerosis, and moderately to severely active Crohn’s disease. (PMS has not been reported in people treated with Tysabri for Crohn’s disease.)
At this time, FDA believes that the benefits of Tysabri continue to outweigh the potential risks.
Recommendation: If you take Tysabri, call your health care professional right away if you get any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, or strength or other problems) that have lasted over several days.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
If you or a family member has been diagnosed with PML, or been treated with Tysabri infusions, contact our law firm to speak to a PML lawyer about your legal options. Every attorney at our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Tysabri has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Tysabri PML Lawsuit with an Attorney.