Recall of Raptiva Psoriasis Medication

On April 8, 2009, Genentech, the manufacturer of Raptiva, issued a voluntary recall of the drug Raptiva, a medication used to treat plaque psoriasis. The recall was issued due to the risk of patients developing a fatal viral disease that affects the brain, known as progressive multifocal leukoencephalopathy (PML).

Following the recall, Genentech implemented a plan to phase the medication out of the United States by June 8, 2009. The development of PML in patients who used Raptiva was rare and usually linked to long-term use of the drug. Those with a weakened immune system were typically the patients at risk of developing PML, which often causes irreversible damage to the brain and death.

Raptiva was administered to patients through an injection every week to treat adults with psoriasis, a common skin condition that often causes flaky, red and irritated skin. The medication was approved by the U.S. Food and Drug Administration (FDA) in 2003.

On October 16, 2008, the FDA included PML on the black box warning list of life-threatening conditions associated with Raptiva. A Public Health Advisory was issued by the administration on February 19, 2009, prompted by reports of patients who developed PML following the use of Raptiva. Of the four reports received, three of the patients with PML passed away. The advisory issued by the FDA warned patients and medical professionals of the risks associated with the development of PML in patients taking Raptiva.

Less than a month later, in March 2009, the FDA approved a Medication Guide for Raptiva with information about PML included on the label of the drug.

Following the recall of the medication, prescribers were informed not to issue Raptiva to new patients and were encouraged to discuss eliminating the medication from the treatment regimen of those currently taking Raptiva.