Tysabri Lawsuits

Side effects of Tysabri have been linked to an increased risk of liver damage, as well as a risk of a rare and potentially fatal brain disease known as Progressive Multifocal Leukoencephalopathy.

STATUS OF TYSABRI LAWSUIT: The potential for legal claims are being investigated and reviewed for users of the multiple sclerosis drug who have been diagnosed with a liver injury or neurological disease.

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MANUFACTURERS: Biogen Idec and Elan Corporation

OVERVIEW: Tysabri (natalizumab) is an intravenous injection used to treat multiple sclerosis (MS) and Crohn’s disease. As of December 2007, approximately 21,000 individuals had been treated with the drug.

The FDA initially approved Tysabri in 2004 as an MS treatment. It is typically administered every 28 days for MS patients to help prevent relapse, cognitive decline and vision loss. In January 2008, the FDA approved Tysabri for treatment of Crohn’s dieases where patients have fialed other treatments, such as Remicade and Humira, as it can prevent relapse in Crohn’s disease and increases the rate of remission.

TYSABRI LIVER DAMAGE: In Feburary 2008, the FDA posted an alert about Tysabri side effects which have been linked to an increased risk of severe liver injury which could lead to death or the need for a liver transplant for some patients.

Biogen Idec, Elan Corporation and the FDA sent a letter to healthcare providers to notify them of report of clinically significant liver injury, including markedly elevated serum hapatic enzymes and elevated total bilirubin, which had occurred in some patients as early as six days after the first dose of Tysabri.

TYSABRI BRAIN DISEASE – PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY: The use of Tysabri has been linked to a rare and potentially fatal neurological disease known as Progressive Multifocal Leukoencephalopathy. This causes inflammation at multiple locations in the brain, leading to permanent brain damage. There is no known cure for the rare disease and it can be fatal in many cases.

In 2005, a temporary Tysabri recall was issued after three cases surfaced of users who developed Progressive Multifocal Leukoencephalopathy. Two of those three died as a result of the brain disease.

The manufacturers re-introduced the drug in 2006 with stricter guidelines for usage and more prominent warnings about PML as a potential Tysabri side effects.

In August 2008, a filing made by the manufacturers with the Securities and Exchange Commission indicated that two new cases of Progressive Multifocal Leukoencephalopathy among Tysabri users had surfaced. These were the first known reports since the drug was re-introduced in 2006, which has caused renewed concerns about the safety of Tysabri, since both users developed the brain disease after using the drug for at least 14 months without any simultaneous use of another multiple sclerosis drug.

Symptoms of the Tysabri brain disease could include:

• Paralysis
• Loss of Vision
• Weakness
• Impaired Speech
• Cognitive Decline

Tags: Progressive Multifocal Leukoencephalopathy (PML), Tysabri