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FDA Warns that Psoriasis Drug Raptiva May Cause Fatal Brain Infection

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There is speculation in the Food and Drug Administration that Raptiva, a drug manufactured by Genentech and prescribed for psoriasis, causes a serious and often fatal brain infection called multifocal leukoencephalopathy (PML).

In a health advisory released February 19, 2009, the FDA alerted the public to three confirmed cases and a suspected fourth case of psoriasis patients being diagnosed with PML after receiving Raptiva. According to the advisory, “Three of those patients have died. All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.”

In light of these findings, the FDA is taking steps to:

    • ensure that the risks of Raptiva do not outweigh its benefits;

    • that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and

    • that health care professionals carefully monitor patients for the possible development of PML.

In October 2008, when it revised Raptiva’s product labeling to highlight, in a boxed warning, the increased risks of life-threatening infections associated with taking the drug, the FDA also directed Genentech to develop a medication guide educating patients about Raptiva’s risks.

Psoriasis is a chronic, non-contagious autoimmune disease affecting between 6 and 7 million Americans, which causes inflamed, red scaly patches, or plaques, to appear on the skin.

Raptiva is given to adults with moderate to severe plaque psoriasis in the form of a once-weekly injection. It works by suppressing the immune system’s T-cells, or infection-fighting cells, which are part of what cause the skin inflammation associated with psoriasis. As the FDA points out, decreasing immune system effectiveness also increases a patient’s susceptibility to infection.

According to the FDA:

PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.

Fortunately, there are many alternatives to Raptiva available to sufferers of psoriasis, including biologic agents, ultraviolet therapy, and several types of drugs.

It is recommended that patients who either currently take Raptiva or have taken it in the past should contact their health care professionals immediately if they have experienced any of the above symptoms.