Raptiva (efalizumab) Associated with Progressive Multifocal Leukoencephalopathy

Two US Patients Dead From PML

Health Canada has issued a warning regarding the risk of serious adverse health effects, including Progressive Multifocal Leukoencephalopathy (PML), occurring in patients receiving Raptiva as treatment for psoriasis. PML is a rare and sometimes fatal brain disorder, caused by the reactivation of a latent virus which results in progressive damage or inflammation of the brain.

The warning results from 2 deaths that occurred in patients in the US who developed PML while being treated with Raptiva for longstanding psoriasis. They are the first confirmed PML fatalities associated with the therapy.

In October, 2008, the FDA mandated a black box warning for Raptiva, because of its association with PML. It is estimated that approximately 46,000 patients have been treated with Raptiva worldwide, since it was first authorized.

DEC-30-08: Association of Raptiva (efalizumab) with Serious Infections, including Progressive Multifocal Leukoencephalopathy in Patients with Psoriasis [HEALTH CANADA: RAPTIVA PML SAFETY WARNING]

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Last updated on Mar-3-09