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 leucoencephalopathy (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 of 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 October 16, 2008, updated Raptiva’s labeling, warning users of the risks of developing life-threatening infections, including PML.
 

Then on February 19, 2009, the FDA issued a public health advisory notifying heathcare professionals and Raptiva users of three confirmed Raptiva-caused PML deaths and other PML diagnosis.   On March 13, 2009, the FDA approved a Medication Guide for Raptiva, which also included information about PML.

Contact Us
Davis & Crump now handling claims for PML, Lymphoma, Thrombocytopenia and brain or blood infections. If you or a loved one have been injured by Raptiva, contact us at 1-800-277-0300 or send us an email at info@daviscrump.com.