FDA Video: Raptiva Withdrawn from the Market

On April 8, 2009 the U.S. Food & Drug Administration (FDA) in association with Genentech began a phased market withdrawal (Raptiva recall) of the psoriasis drug Raptiva (efalizumab).  Included below is a video issued from the FDA regarding the Raptiva recall.

Full Video Transcript

Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by the JC virus, is a rapidly progressive and irreversible infection of the central nervous system that leads to death or severe disability. Although the overall risk of PML for patients on Raptiva is low, it appears to be increased in long-term users of the drug and in those with compromised immune systems.

Prescriptions for Raptiva will no longer be refilled after June 8, 2009, and so prescribers should not start Raptiva treatment in any new patients. Patients already on Raptiva should be counseled about the risks of the drug, and prescribers should immediately begin discussing alternative therapies with them. Genentech’s letter to prescribers suggests that they carefully manage their patients’ transition from Raptiva to other therapies, and consider that abrupt discontinuation of the drug might seriously worsen the patient’s psoriasis.

After Raptiva treatment is stopped, prescribers should continue to carefully monitor patients for any signs or symptoms suggestive of PML, as well as for infections and other adverse effects.