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March 5, 2005

Rare Infection Is Confirmed in 2nd Patient on M.S. Drug Tysabri

Topics: Clinical Pharmacology

Tysabri is back in the news again. Back in January I warned that:

"This treatment sounds promising but I'd like to see much more data over a longer period of time. MS patients should always take into account the long-term effects of the immunosuppressive effects resulting from their MS medications. This drug should be less immunosuppressive than the standard ABCs, but I was unable to find studies on the immunosuppressive effects of Tysabri, specifically."

Now we are hearing that two patients have developed Progressive Multifocal Leukoencephalopathy after taking the drug, a condition that primarily affects individuals with suppressed immune systems.  In February, the drug was pulled off the market by Biogen Idec and Elan after one patient died and another developed a serious disease of the central nervous system after taking it in combination with Avonex for more than two years. But now we have:

- The New York Times

(...) The makers of the multiple sclerosis drug Tysabri said yesterday that a second patient who used the drug had been confirmed to be suffering from a rare but deadly brain infection. The confirmed diagnosis is likely to somewhat diminish the chances that the drug will be able to return to the market.

(...) The brain infection, called progressive multifocal leukoencephalopathy, or P.M.L., is extremely rare, so even one confirmed case raised alarms, officials of the companies have said. The confirmation of a second case is stronger evidence that the disease is linked to the drug.
- end item

Taking immunosuppressive drugs for any reason is dangerous, and should be avoided whenever possible. The continued practice of treating multiple sclerosis with powerful immunosuppressive drugs is dangerous and irresponsible unless no other treatments are available that can help the patient cope physically, mentally, and emotionally with their disease. Few patients actually die of multiple sclerosis, but many people die from cancer and other fatal diseases, all of which can be attributed to immunosuppression. We simply have to get smarter in treating this disease, and although in aggressive forms of chronic progressive multiple sclerosis there may not be an alternative to immunosuppressive drugs, relapsing remitting MS patients should think twice before taking such treatments.

Posted by Hyscience at March 5, 2005 10:33 AM



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