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The psoriasis drug Raptiva® has been recalled from the market after it was linked to fatal brain disease in some patients, according to the Food and Drug Administration (1).

Raptiva, which was on the market from 2003-2009, was used to treat psoriasis, a skin condition that affects between six and seven million Americans. Raptiva was injected once weekly and worked by suppressing the immune system, a method that may have severe and life-threatening side effects (2).

Update 4/8/09:

Genentech Inc. announced it was withdrawing Raptiva from the U.S. market because of an increased risk of progressive multifocal leukoencephalopathy, a rare and usually fatal disease of the central nervous system. The company said, "Physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving Raptiva to assess the most appropriate treatment alternatives."

Psoriasis appears on the skin, usually in the form of thick, red, scaly patches. According to the National Psoriasis Foundation, psoriasis is a chronic disease associated with other health problems such as diabetes, heart disease, and obesity.

FDA Warns of Meningitis, Sepsis, PML in Raptiva Users

Before the Raptiva recall, the FDA required a “black box” warning—the strongest possible available—on Raptiva’s packaging after it was discovered that using the drug poses a risk of developing rare but fatal infections and diseases (2).

The black box warning highlighted the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy (PML), and other opportunistic infections (a term that describes infections that do not typically affect healthy immune systems, but instead infect people with weakened immune systems).

Signs and Symptoms of Raptiva Health Problems

According to the FDA, patients taking Raptiva should be aware of the following symptoms of various diseases and infections including:

PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems)
anemia (dizziness upon standing, weakness or jaundice)
thrombocytopenia (bruising, bleeding gums, pin-point-sized red or purple dots under the skin)
worsening of their psoriasis or arthritis

Signs of a nervous system disorder include sudden onset of numbness, tingling, or weakness in the arms, legs, or face (2).

If you or someone you care about has used Raptiva and suffered severe or life-threatening side effects, or were diagnosed with progressive multifocal leukoencephalopathy (PML), our law firm wants to put its resources to work for you and help get you and your loved ones the help you need.

Sources:

1) “FDA Public Health Advisory, Updated Safety Information about Raptiva (efalizumab),” from the Food and Drug Administration. Accessed 3/16/09 via www.fda.gov.
2) “FDA Approves Updated Labeling for Psoriasis Drug Raptiva,” from the Food and Drug Administration. Accessed 3/16/09 via www.fda.gov.

Raptiva® is a registered trademark of Genentech, Inc. and is used here only to identify the product in question.

This law firm is not affiliated with, sponsored by, or associated with the Food and Drug Administration, Genentech, Inc., or the National Psoriasis Foundation.

This article is for informational purposes only and does not constitute medical advice. Please see your doctor if you have concerns regarding this medication.

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