Tysabri
Frequently Asked Questions
Pharmaceutical Injury Lawyers
What is Tysabri?
Why was Tysabri taken off the market?
What is multiple sclerosis?
What is PML?
What is accelerated approval?
How is Tysabri taken?
What are the side effects of Tysabri?
Can Tysabri still be purchased?
What is Tysabri? Tysabri (or Natalizumab) is a monoclonal antibody. Tysabri prevents inflammatory cells from entering the brain. Tysabri has been shown to reduce the frequency of multiple sclerosis relapses.
Why was Tysabri taken off the market? According to the FDA, the manufacturers “suspended marketing of Tysabri (natalizumab) due to two serious adverse events reported with its use.” Biogen Idec & Elan, the manufacturers of Tysabri, reported one confirmed, fatal case and one possible case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for multiple sclerosis (MS).”
What is multiple sclerosis? Multiple sclerosis (MS) is a disease that causes the immune system to attack a patient’s brain and spinal cord.
What is PML? PML, or Progressive Multifocal Leukoencephalopathy, is a rare, serious, progressive neurologic disease, usually occurring in immunosuppressed patients, often resulting in irreversible neurologic deterioration and death. There is no known effective treatment for PML, although reversing immune system suppression may slow or arrest progression of the disease.
What is accelerated approval? Accelerated approval is a program the FDA uses when new drugs become available for serious or life-threatening diseases. These drugs must appear to provide a benefit over the available treatments. These drugs are approved based on early clinical evidence. The approval is contingent on the manufacturer’s continued testing and demonstration that the drug provides the purported benefit.
How is Tysabri taken? Tysabri is administered intravenously once every four weeks.
What are the side effects of Tysabri? A clinical study has revealed that Tysabri may cause the rare brain disease progressive multifocal leukoencephalopathy (PML). PML very rapidly strips the lining from nerves in the brain. PML is often fatal.
Can Tysabri still be purchased? No. The manufacturers voluntarily withdrew Tysabri from the market on February 28, 2005.
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If you or a loved one has been harmed by Tysabri, you need a law firm with the resources and the experience to bring you justice. Please call or e-mail the Tysabri attorneys at Kline & Specter. We'll evaluate your claim for free and we don't get paid unless you do. Our expertise will help you get the compensation you deserve.
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This page was last updated on January 31, 2007.
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