Drug manufacturer acts after link found to rare brain infection
WEDNESDAY, April 8 (HealthDay News) -- The troubled psoriasis drug Raptiva is being withdrawn from the U.S. market, California-based drug maker Genentech announced Wednesday.
The move comes almost two months after U.S. health officials issued a public health advisory on the drug after confirming a link to a rare, sometimes fatal brain infection.
In a prepared release, Genentech said Wednesday, "Effective immediately, 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. Raptiva will no longer be available after June 8, 2009."
Genentech estimated that approximately 2,000 patients in the United States may currently be using Raptiva (efalizumab) for chronic plaque psoriasis. Since it was approved by the U.S. Food and Drug Administration in 2003, approximately 46,000 patients worldwide have been treated with Raptiva, the company said.
"Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety," said Dr. Hal Barron, Genentech's senior vice president, development and chief medical officer. "Although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed."
In February, an FDA advisory noted there had been three deaths of people taking the drug. Two involved people with confirmed cases of a rare brain infection called progressive multifocal leukoencephalopathy (PML). The third death was a person believed to have contracted the brain infection, according to the advisory.
All had been treated with Raptiva for at least three years, and none was taking other immune suppressants.
In its advisory, the FDA said it wo
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