The California-based drug firm Genentech has announced a voluntary, phased withdrawal from the market of its psoriasis drug Raptiva, which has been linked to a rare but usually fatal brain infection.

Genentech’s action

As of last October, three cases of the disorder, progressive multfocal leukoencephalophathy (PML) had been reported to the Food and Drug Administration in patients taking Raptiva, two of them fatal. A fourth patient with possible PML also died. All of the patients, ages 47-73 years had been taking the drug for at least three years.

“Our decision to remove Raptiva from the market reflects Genentech’s commitment to patient safety,” Hal Barron, MD, the firm’s Senior Vice President for Development and Chief Medical Officer, said in a statement. “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.”

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The company estimates that 2,000 patients in the US currently taken the drug and that 46,000 patients worldwide have taken the drug.

In a letter to Raptiva patients, Dr. Barron advised them not to stop taking Raptiva without first talking to a physician because sudden withdrawal could have serious side effects, such as worsening of the psoriasis leading to hospitalization.

“There is no way to know ahead of time who will get PML,” he wrote. “There is no treatment or cure for PML. People who do live with PML are severely disabled.”

To give physicians time to withdraw patients from the drug and change treatment, pharmacies will be able to refill prescriptions until June 8, 2009, however, no new prescriptions will be filled.

Background

The FDA approved Raptiva for treatment of moderate to severe plaque psoriasis in 2003. No cases of PML were seen in the 2,764 patients treated with Raptiva in the clinical trails that led to the approval of the drug. Of those patients, 2400 had been treated for two months, 904 for six months, and 218 for one year or longer.

Last fall the Food and Drug Administration ordered Genentech to change the Raptiva label to highlight in a boxed warning the risks of life-threatening infections, including PML. A Public Health Advisory alerting to the risk of PML, which is a rare, progressive neurological disease caused by a virus that affects the central nervous system, followed the action in February.

Regulators in Europe, Canada, and Malaysia have recommended that the drug be withdrawn from the market.

Potential for lawsuits

Geentech’s withdrawal of Raptiva is expected to lead to a flood of lawsuits. A recent Supreme Court ruling, Wyeth V. Levine, holding that a patient injured by a drug can sue the maker even though the Food and Drug Administration oversees warnings on drug labels about possible side effects opens the door for plaintiff suits.

If you or any member of your family uses Raptiva, consult your physician first, and then call an attorney immediately.

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