Plaintiffs v Raptiva
Raptiva Withdrawn From Market for High Risk of Fatal Brain Disease
A phased withdrawal of the psoriasis drug Raptiva (efalizumab) from the U.S. market has been announced by the drug manufacturer Genentech.
Since October 2008, Raptiva has been associated with a higher risk for progressive multifocal leukoencephalopathy (PML), a rare, and often fatal neurologic viral disease that affects the central nervous system. The associations between Raptiva and PML are generally associated with individuals with weakened immune systems.
Symptoms of PML may include:
-Unusual weakness
-Loss of coordination
-Changes in vision
-Difficulty speaking
-Personality changes
-Other neurological changes
-Death
There are no known effective therapeutic options for PML, and no known screening tests that can reliably predict PML. The PML infection often leads to an irreversible decline in neurologic and brain function and death. People who live with PML are severely disabled.
The product withdrawal plans to remove Raptiva by June 8, 2009. According to the FDA, prescribers should not initiate new Raptiva treatment. The phased withdrawal is designed to allow patients time to find other effective treatments for psoriasis so as to avoid severe worsening of the condition or hospitalization.
Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.
Genentech began receiving reports of PML among Raptiva users as early as September 2008. On October 16, 2008, the Raptiva label was updated to warn of the risk of life-threatening infections, including PML. A Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva was issued in February 2009, after four patients developed PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in the drug's labeling regarding PML.
