A Public Health Advisory, recently issued by the FDA confirms three deaths, and possibly a fourth from progressive multifocal leukoencephalopthy (PML), a rare brain infection, in patients using the drug, efalizumab (Raptiva) made by Genentech, Inc.
The labeling for Raptiva was updated in October 2008 to include a Boxed Warning, highlighting the risks of life-threatening infections, including PML.
Genetech was also directed Genentech, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to include a medication guide intended to educate patients about the drug’s associated risks.
PML is a rare and often-fatal brain infection, where there is inflammation of the brain’s white matter. Patients with a severely compromised immune system are at risk of suffering from an irreversible brain function and possibly death. No treatment exists for PML.
The FDA is reviewing the latest information and will take appropriate measures to ensure that the risks of Raptiva do not outweigh its benefits, and that patients prescribed Raptiva are fully aware of the signs and symptoms of PML.