FDA Advisory Announces Psoriasis Drug Raptiva Increases Rare, Fatal Brain Infection Risk

Main Category: Eczema / Psoriasis
Also Included In: Dermatology;  Neurology / Neuroscience
Article Date: 16 Mar 2009 - 3:00 PDT

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A recent FDA public health advisory announced that psoriasis drug Raptiva® can increase the risk of developing a rare, fatal brain infection called progressive multifocal leukoencephalopathy (PML), and confirmed reports of the infection in three deceased patients who had taken the drug for more than three years.

"The FDA knew of Raptiva's® potentially life-threatening effects and issued a black-box warning in October 2008, highlighting the drug's risk of bacterial sepsis, viral meningitis and other infections. While the European Medicines Agency (EMEA) and Health Canada recently suspended drug sales, the FDA has decided to monitor its effects," said Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley, P.C. attorney Gregory Spizer, who serves as counsel to victims suffering injuries from Vioxx, Digitek, Trasylol, Fosamax, Zelnorm, Avandia and other dangerous drugs.

"This is another drug that was put on the market too early, and consumers have suffered the consequences. Pharmaceutical companies should be obligated to study the long-term effects of their drugs and conduct follow-up studies even after the clinical trial phase," says Spizer. "The FDA needs to hold these companies accountable before more people are injured."

According to the National Psoriasis Foundation, more than five million Americans have psoriasis, and spend between $1.6 billion and $3.2 billion each year to treat the disease. Manufactured in the U.S. by San Francisco-based biotech giant Genentech, Raptiva® is administered by weekly injections and works by suppressing the immune system to reduce psoriasis flare-ups. However, in suppressing the body's natural defense system, it can also increase patients' risks of serious infections and malignancies.

PML can worsen over time and attack many parts of the brain simultaneously. The infection is caused by loss of the brain's white matter which protects nerve fibers. Without white matter, nerve signals don't travel from the brain to the rest of the body. Affected patients typically experience symptoms ranging from clumsiness, progressive weakness, and changes in visual acuity, speech and personality.

"Consumers should consult with their physicians to stay informed about the serious risks and side effects of their prescription drugs," says Spizer. "And, they should work with their medical professional to decide whether they should wait to take a drug that's new to the marketplace."

Founded in 1977, Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley, P.C., is a personal injury firm with more than 25 attorneys and law offices in Philadelphia, Media, Reading and Harrisburg, Pa., as well as Cherry Hill, N.J. and Wheeling, W.Va. The firm has a multi-faceted practice with a tradition of excellence in pharmaceutical mass tort, medical device matters, toxic tort, class actions, products liability, workplace injury, professional negligence cases, automobile, investor claims and wrongful termination litigation.

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