FDA Issues Warning to San Diego About the Psoriasis Drug, Raptiva
The Food and Drug Administration has issued a warning to San Diego doctors specializing in dermatology and patients about the psoriasis drug efalizumab, or Raptiva. This warning is linked to three deaths and possibly a fourth.
The three that were confirmed dead were all taking the drug Raptiva and were reported to have had a rare brain infection called progressive multifocal leukoencephalopathy (PML). In October of 2008, the FDA forced the drug maker, Genentech to highlight in a warning regarding the risks of life-threatening infections, including PML, on their product packaging.
The FDA has also directed Genentech to develop a Risk Evaluation and Mitigation Strategy to ensure that patients receive risk information about Raptiva. Also, the FDA wants to make sure that the risks do not outweigh the benefits.