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.

For more information, please visit: more information here

Source: Manufacturer
Publication Date: 2010-01-29
Last Updated: 2010-01-29

Visit the medication page for the following drugs:

Share your story Share your story! Tell us how MediGuard has helped you or someone you love. Mobile graphic Download the MediGuard Mobile App to manage your prescription and over-the-counter medications, for free. Registration Info Taking multiple medications puts you at risk for possible drug-drug interactions Registration Info Monitor the medical treatment of you and your loved ones.