Safety Alerts & Recalls

What does this mean?

The issue of PML with Tysabri use has been known for some time and under the TOUCH Prescribing Program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious infections. However, it is a good idea to follow up with your doctor to review your benefits of Tysabri treatment and the updated PML risk information for Tysabri. You should also 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.

Update on Risk of Progressive Multifocal Leukoencephalopathy (PML) in Tysabri Patients

The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. PML is a rare but life threatening disease of the brain and nervous system. Tysabri is approved for the treatment of relapsing forms of multiple sclerosis (MS) and for moderately to severely active Crohn's disease. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for Multiple Sclerosis with Tysabri alone, without other immunosuppresants. Of these, four cases were patients in the United States (U.S.). There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn's disease.

Based on the current information available, the following observations have been made: 1) The risk for developing PML appears to increase with the number of Tysabri infusions received. The number of monthly infusions of Tysabri in the 13 patients who developed PML ranged from 12 to 35 infusions. The average number of infusions received before the diagnosis of PML was 25.

2) The overall rate of developing PML with Tysabri therapy in patients who have received at least one infusion remains below 1 per 1,000 patients. The current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.

At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program.

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Source: FDA
Publication Date: 2009-09-17
Last Updated: 2009-12-05

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