FDA says 3 deaths associated with Genentech psoriasis drug PDF Print

WASHINGTON (AP) — Three patients taking a Genentech psoriasis drug have died of a rare brain infection, a known risk with the skin-clearing treatment, according to federal health officials.

The Food and Drug Administration on Thursday confirmed three cases and a possible fourth of progressive multifocal leukoencephalopathy, or PML, which causes swelling of the brain and is usually fatal. The patients had been taking Genentech's once-a-week injection Raptiva, which is used to treat red, scaly skin caused by psoriasis.

Regulators did not say when the deaths occurred.

The FDA in October added its most serious warning to Raptiva, after a 70-year-old patient died from PML while taking the drug.

The agency stressed in a statement posted to its website that patients should be aware of the symptoms of the infection, which include weakness, blurred vision and difficulty speaking. Doctors should likewise monitor patients taking the drug for these signs, the FDA said.

PML is typically seen in patients with weakened immune systems, and previously has been reported in patients taking Rituxan, a blockbuster arthritis and cancer drug marketed by Genentech (DNA) and Biogen Idec.

Calls placed to South San Francisco-based Genentech were not immediately returned Thursday.

Copyright 2009 The Associated Press.
 
© 2008 leflaw.com design by tracy feldman