FDA Issues New Health Advisory For Psoriasis Drug Raptiva

The Food and Drug Administration has just issued a health advisory in response to reports of deadly brain infections in people who use the psoriasis drug Raptiva. There have been  three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in people taking Raptiva. Of those four people, three are now dead. All patients has been treated with Raptiva for at least three years.

Rapitiva is manufactured by Genentech and was approved in 2003 for the treatment of moderate to severe psoriasis in adults. Psoriasis is a chronic disease, for there are a number of therapeutic options are available. They include four other approved biologic agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin, and methotrexate. Generally, treatment for psoriasis patients involves a rotation of therapies. Raptiva is given by injection once a week to control the disease. It works by suppressing T-cells in the immune system to reduce psoriasis flare-ups, but in doing so, can raise the risk of a rare and usually fatal viral disease of the brain called progressive multifocal leukoencephalopathy (PML). PML affects the central nervous system and usually occurs in people whose immune systems are already functioning below normal levels. Symptoms of PML include weakness, changes in vision, difficulty speaking, loss of coordination and changes in personality.

Black Box Warning

In October 2008, Raptiva’s label got a “black box” warning, the strongest warning the FDA can give. This warning will highlight the risk of opportunistic infections which include bacterial sepsis, viral meningitis, invasive fungal disease and PML.  Take note though, that although the FDA is warning people about the dangers of this drug, and to seek medical attention if symptoms develop, it is not telling people to stop taking Raptiva.

Genentech says it plans on issuing letters to doctors and health care providers notifying them of the label changes. The FDA has also required Genentech to develop a medication guide and other literature for the packaging. This is not the first time though that Genentech has been warning regarding Raptiva. In July 2005, the FDA ordered Genentech to strengthen the saftey warnings on this drug in an attempt to warn users about immune-mediated hemolytic anemia, a side effect that can occur when the immune system mistakes oxygen-carrying red blood cells for foreign substances and destroys them.

The FDA is reviewing all reports regarding Raptiva and its side effects and says that it will take the appropriate steps to ensure that the risks of taking this drug do not outweigh its benefits.

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