The decision is based on Raptiva’s link to an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.
PML is a progressive neurological disease with no available treatment. Patients with a severely compromised immune system are at risk of suffering from an irreversible brain function and possibly death.
In February, the FDA issued a Public Health Advisory warning patients about the associated risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died.
The labeling for Raptiva was updated in October 2008 to include a Boxed Warning highlighting the risks of serious infections, including PML.
Approximately 2,000 patients in the U.S. are currently taking Raptiva for chronic plaque psoriasis. Approved by the FDA in 2003, about 46,000 patients worldwide have been treated with Raptiva.
Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online.