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The U.S. Food and Drug Administration (FDA) announced a voluntary Raptiva recall, April 8, 2009. The Psoriasis drug’s manufacturer, Genentech, announced the voluntary Raptiva recall and has begun phasing the drug off the U.S. market. Raptiva will no longer be sold on the U.S. market after June 8 2009.

Genentech issued a recall of the Raptiva drug because of the risk to users of developing a rare and potentially fatal brain infection, progressive multifocal leukoencephalopathy (PML). PML, although rare, has been linked to long-term Raptiva use. PML is an irreversible progressive neurological disease that attacks the central nervous system. Currently, there is no cure for PML.

Symptoms of Raptiva-Caused PML

PML is a serious brain infection that attacks the white matter surrounding the nerve fibers, causing serious trauma, permanent disability and, in most cases, death. Depending on what part of the brain that is being infected, PML symptoms can include:

• Weakness, clumsiness
• Visual impairments
• Speech problems, slurring words
• Changes in personality

FDA Advises All Raptiva Users to Stop Treatment

In the announcement notifying users and healthcare professionals about Genentech’s Raptiva recall, the FDA strongly advises patients who are currently taking Raptiva medication to stop use immediately and discuss a new treatment plan with their doctors. Genentech has also asked Raptiva prescribers to work with patients on alternative treatments.

History of Raptiva and PML

Raptiva, sold generically as efalizumab, was approved by the FDA in 2003 as a treatment for Psoriasis, a chronic disease that attacks the immune system. After being on the market for five years, the FDA became aware of the link between Raptiva and PML and, on Oct. 16, 2008, updated Raptiva’s labeling, warning users of the risks of developing life-threatening infections, including PML.

Then, on Feb. 19, 2009, the FDA issued a Public Health Advisory notifying healthcare professionals and Raptiva users of three confirmed Raptiva-caused PML deaths and another PML diagnosis. On March 13, 2009, the FDA approved a Medication Guide for Raptiva, which also included information about PML.

(Source: FDA)

Have you or a loved one been diagnosed with PML or another infection following a Raptiva treatment? If so, you are eligible to recover compensation for your losses. For more information and legal guidance, please contact a Raptiva Lawyer today.