Tysabri, a drug used to treat multiple sclerosis and Crohn’s disease, has been linked to progressive multifocal leukoencephalopathy (PML). Biogen Idec, Inc., the maker of Tysabri is reinstituting its practice of providing monthly updates on PML, which is an often fatal brain infection. With this monitoring plan, doctors will be updated about new PML cases at the middle of each month. Access to this information will be through a password-protected website. The site will have information on the number of PML cases, details on the duration of use, and a cumulative patient exposure figure. Patients can request information from Biogen, but they will not receive as detailed information as doctors, due to regulations that restrict direct interaction between patients and drug companies.
In 2005 Tysabri was taken off the market in the U.S, after 3 clinical trial patients developed PML. In 2006, Tysabri was reapproved, but with restrictions. Currently, only patients with relapsing MS or Crohn’s disease can receive Tysabri, and they must be enrolled in the risk minimization plan called the TOUCH Prescribing Program. As of mid-January 2010, the number of Tysabri patients who have developed PML is 31.
if you have taken Tysabri, and developed PML, contact Sheller, P.C. Sheller has a long history of successfully representing patients who have been harmed by pharmaceuticals. Contact Sheller to discuss your potential legal claims.