Raptiva Withdrawn

On Monday, June 9, 2009, the psoriasis medication RAPTIVA was officially withdrawn from the U.S. market by its manufacturer, Genentech, Inc., stemming from risks that users may develop progressive multifocal leukoencephalopathy (PML). PML is a rare and usually fatal viral disease that occurs almost exclusively in people with severe immune deficiency. According to the U.S. Food & Drug Administration, there have been three confirmed and one possible case of progressive multifocal leukoencephalopathy (PML) in people taking Raptiva. Three of those people have died.

On Monday, June 9, 2009, the psoriasis medication RAPTIVA was officially withdrawn from the U.S. market by its manufacturer, Genentech, Inc., stemming from risks that users may develop progressive multifocal leukoencephalopathy (PML).

PML is a rare and usually fatal viral disease that occurs almost exclusively in people with severe immune deficiency.  According to the U.S. Food & Drug Administration, there have been three confirmed and one possible case of progressive multifocal leukoencephalopathy (PML) in people taking Raptiva.

Three of those people have died.

Following an October 2008 “black box” warning (the FDA’s strictest warning) about the increased risk of life-threatening infections, including PML, Genentech issued a public health advisory in February.  The decision to discontinue the medication was subsequently made in April, 2009.

Raptiva is a once-weekly injection for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. Raptiva suppresses T-cells, which are part of the immune system, to curb psoriasis. While suppression of T-cell activity reduces the severity of users’ psoriasis symptoms, it increases a patient’s susceptibility to infections.  There is no known cure for PML.

According to Genentech, there are an estimated 2,000 current users of Raptiva; since FDA approval in 2003, approximately 46,000 patients worldwide have been treated with Raptiva.