Tysabri, a drug used to treat patients with multiple sclerosis and Chrone’s disease, may cause liver damage within six days of use according to new information from the drug’s manufacturers Biogen Idec, Inc. and Elan Pharmaceuticals, Inc. The companies have issued warnings to doctors and patients.

What is Tysabri?

Originally prescribed to patients suffering from multiple sclerosis (or MS, a chronic, unpredictable neurological disease that affects the central nervous system), Tysabri was pulled from US markets in 2005 after it was linked to a rare, but fatal, brain infection. However, it was reintroduced in 2006 after the Food and Drug Administration (FDA) decided that the drug’s benefits to MS patients outweighed the risks of brain infections.

In January 2008, the FDA approved Tysabri for the treatment of moderate to severe Chrone’s disease, an incurable disease that affects the bowels. However, use of the product has been linked to liver damage, in some cases after only six days after taking it, according to the drug’s manufacturers.

Warning letters issued

Biogen and Elan have released warning letters to doctors and patients about the potential injuries associated with the drug. According to the letters, published on the FDA’s website (www.fda.gov/), “[S]ignificant liver injury has been reported in patients treated with Tysabri. Signs of liver injury . . . occurred as early as six days after the first dose . . . and have also been reported for the first time after multiple doses.” The letters also state that, “[S]evere liver injury . . . may lead to death or the need for a liver transplant in some patients” and that “Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury.”

Additional information

For additional information on Tysabri, see the manufacturer’s website at www.tysabri.com or contact them at 1-800-456-2255. To view recently released doctor and patient warning letters, see the FDA’s MedWatch website at: http://www.fda.gov/medwatch.

If you or a loved one has been injured due to Tysabri use, contact an attorney whose practice focuses in this area of law to discuss your situation. Consultations are free, without obligation and strictly confidential. To contact a qualified attorney, please click here.