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Here is the latest update from the FDA on Tysabri (Natalizumab)
This is much the same as what has been indicated before, but maybe someone has not seen it yet.
Safety Announcement
[02-05-2010] 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 information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will 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 2006, Tysabri has only been available through a risk minimization plan called Tysabri Outreach Unified Commitment to Health (the TOUCH™ Prescribing Program). The program, developed by the FDA and the manufacturer of Tysabri, Biogen-Idec, is intended to make sure that healthcare professionals and patients understand the benefits and potential risks associated with the use of Tysabri, including the risk of PML.Under the TOUCH™ program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections. For additional information about the TOUCH™ program click here.
Based on the available information, the FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases.
http://www.fda.gov/Drugs/DrugSafety...ormationforPatientsandProviders/ucm199872.htm
This is much the same as what has been indicated before, but maybe someone has not seen it yet.
Safety Announcement
[02-05-2010] 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 information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will 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 2006, Tysabri has only been available through a risk minimization plan called Tysabri Outreach Unified Commitment to Health (the TOUCH™ Prescribing Program). The program, developed by the FDA and the manufacturer of Tysabri, Biogen-Idec, is intended to make sure that healthcare professionals and patients understand the benefits and potential risks associated with the use of Tysabri, including the risk of PML.Under the TOUCH™ program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections. For additional information about the TOUCH™ program click here.
Based on the available information, the FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases.
http://www.fda.gov/Drugs/DrugSafety...ormationforPatientsandProviders/ucm199872.htm
