PML & Tysabri® (Natalizumab)
If you or a loved one has been diagnosed with progressive multifocal leukoencephalopathy (PML) after being treated with Tysabri®, please contact our PML attorneys. We understand the devastating consequences of PML and work hard to recover full financial recoveries for those affected by the terrible illness. Contact us for a free consultation today.
What is Tysabri®?
Tysabri® (natalizumab) is an immunomodulator, a class of drugs that prevents certain cells of the immune system from damaging the body. The U.S. Food and Drug Administration (FDA) approved the medication in November 2004 to treat relapsing forms of multiple sclerosis and in January 2008 to treat moderate to severe Crohn's disease.
In April 2011, the FDA issued a safety announcement stating it was continuing to evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare by serious brain infection, when patients used Tysabri®.
PML is a life-threatening debilitating disease that rapidly worsens over time and usually ends in death. Patients with PML suffer side effects that include increasing problems with clumsiness and coordination; loss of ability to speak, listen, read, and write; weakening of the arms and legs; memory loss; and cognitive problems.
FDA Safety Alert for Tysabri®
At the time of the FDA announcement, the agency revised the drug label to include a new table that summarized the rates of PML according to the number of infusions of the drug, or how long the drug was taken or the duration of exposure. The label also includes information on a newly recognized PML risk factor:
- Patients who took an immunosuppressive (suppressing the immune system) medication such as mitoxantrone, azathioprine, methotrexate, cyclophosphamide or mycophenolate prior to taking Tysabri® were found to be at increased risk of developing PML.
- The label on Tysabri® already stated that taking these immunosuppressive agents at the same time as Tysabri® might increase the risk of developing PML.
The FDA also stated in its announcement that based on available information it continued to believe that the benefits of taking Tysabri® outweighed the potential risks.
The drug is available only through a restricted distribution program called TOUCH:
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Additional information the FDA announcement stated was:
- Tysabri® continues to be associated with PML
- The risk of developing PML increases with the number of infusions
- The risk of developing PML also increases if the patient has taken an immunosuppressant medication in the past
- Patients currently taking immunosuppressive or immunomodulatory therapy should not be using Tysabri®
- Patients who have diseases that compromise their immune systems should not take the drug
Tysabri® was temporarily recalled from the market in 2005 after three patients in clinical trials developed PML. In July 2006, the drug was reinstated.
The FDA announcement and the medication label state that 102 cases of PML had been reported among 87,732 patients using Tysabri® worldwide through Feb. 28, 2011. Data from 2010, the FDA announcement said, confirmed that the risk of developing PML is greater in patients given more than 24 Tysabri® infusions (or the same as receiving Tysabri® for over two years) compared to patients receiving fewer than 24 infusions.
PML & Tysabri® Lawsuit
If you or a loved one has taken Tysabri® and suffered from PML, you should contact an attorney who can help you receive compensation for the pain and suffering of this devastating disease. Our PML lawyers represent patients that have taken this drug and have been diagnosed with PML. We also represent families who have lost loved ones. To schedule a free case review, please contact us today.