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FDA Drug Safety Communication: Risk Of Progressive Multifocal Leukoencephalopathy (PML) With The Uuse Of Tysabri (Natalizumab)

Posted Feb 05 2010 2:47pm

The U.S. Food and Drug Administration (FDA) is alerting the public that the risk of developing progressive multifocal leukoencephalopathy (PML)a rare but serious brain infection associated with the use of Tysabri (natalizumab)increases with the number of Tysabri infusions received. This new safety informationbased on reports of 31 confirmed cases of PML received by the FDA as of January 212010will now be included in the Tysabri drug label and patient Medication Guide (see Data Summary for additional information).
Tysabri was approved by the FDA in November 2004 for the treatment of relapsing forms of multiple sclerosis (MS). Tysabri is also approved by FDA for treating moderately to severely active Crohn’s disease.

Since 2006Tysabri has only been available through a risk minimization plan called Tysabri Outreach Unified Commitment to Health (the TOUCH™ Prescribing Program). The programdeveloped by the FDA and the manufacturer of TysabriBiogen-Idecis intended to make sure that healthcare professionals and patients understand the benefits and potential risks associated with the use of Tysabriincluding the risk of PML.Under the TOUCH™ programevery patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections.

Based on the available informationthe FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guidewith the continued use of the TOUCH Prescribing Programare intended to maximize the safe use of Tysabri and the identification of new PML cases.

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