The Raptiva Timeline

From Approval to Recall

In September 2003, the FDA's advisory committee unanimously approved Genentech's drug Raptiva for treatment of moderate to severe plague psoriasis.

The committee members expressed optimism about the speed with which Raptiva helped ease psoriasis symptoms. However, even while the committee recommended that the U.S. Food and Drug Administration (FDA) approve the drug, committee members expressed concern about "the lack of evidence concerning the drug's long term safety." Ultimately, it would be the drug's long term safety that would lead to its final recall less than 6 years after its initial approval in October 2003.

FDA Concern about dangerous PML condition in Raptiva Patients

On October 16, 2008, the FDA first informed the public of its concern about Raptiva's connection with the often fatal — and always dangerous — progressive multifocal leukoencephalopathy (PML) infection. At that time, the FDA knew of one confirmed case of PML in a Raptiva patient. Accordingly, the agency approved updated labeling of Raptiva which included informing patients about the potential dangers of PML and explaining the warning symptoms of the infection which would require immediate medical attention.

Just four months later, on February 19, 2009, the FDA issued an FDA Public Health Advisory about Raptiva. The reason for the Public Health Advisory was that the FDA had learned of three confirmed cases of PML and one potential case of PML in Raptiva patients. All of the PML patients had been taking Raptiva for more than three years and none of them were taking other medical treatments that would suppress their immune systems. Three of the four PML patients died from the PML infection which, while rare, is almost always fatal and has no known treatment. Accordingly, the FDA advised patients and physicians that it was reviewing the information received about Raptiva side effects to determine whether the risks associated with the drug outweighed its known benefits. In its February 2009 advisory, the FDA advised patients and physicians to exercise caution and to be aware that "Raptiva increases the risk of PML."

A few weeks after the FDA's February 19 Public Health Advisory concerning Raptiva, Genentech, the drug's manufacturer, revised its prescribing information for the drug. The March 2009 updates were made in several sections of the prescribing information to highlight the risk of PML as a possible Raptiva injury. The patient medication guide was also revised and doctors were urged to make sure that patients understood the risk of PML and the early symptoms of the infection. Doctors were also urged to closely monitor Raptiva patients and to continually weigh the risks and benefits for each patient to determine if continued use of the drug was appropriate.