Safety Alerts & Recalls
What does this mean?
With this new program doctors will receive monthly updates about new cases of PML in patients who receive Tysabri. At each of your infusion visits, you can ask your doctor to review these monthly updates with you and help you weigh the benefits against the risks of continuing Tysabri. You can also call Tysabri Patient Services for more information about Tysabri at 1-800-456-2255 (Monday to Friday, 8:30am to 8:00pm ET).
Between your clinic visits, you should continue to monitor for symptoms of PML - please contact your doctor immediately if you notice any changes such as weakness in the hands or legs, difficulty thinking or concentrating, or a loss of coordination - which could be early signs of the condition.
Biogen Idec Announces Monthly Update of Tysabri Monitoring Program
Biogen Idec Inc. announced a new plan to communicate with doctors once a month on the occurrence of new cases of Progressive Multifocal Leukoencephalopathy (PML) in patients using its multiple sclerosis treatment Tysabri. PML is a rare but life threatening disease of the brain and nervous system. Under the new plan, Biogen will update doctors midmonth and provide information through a password- protected Web site. It will include the number of PML cases, with an incidence rate broken down by duration of Tysabri use.
Patient services will provide Tysabri patients with information upon request, although not with the level of detail given to doctors. The reason for the difference between how doctors and patients are updated is because of government regulations that restrict direct interactions between patients and drug companies.
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