FDA Raptiva Recall Statement
April 8, 2009
Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.
Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.
The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.
Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.
Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML.
SOURCE: U.S. Food and Drug Administration (FDA)
FDA Reports and Raptiva News
- 04/08/2009 - FDA Raptiva Recall Statement
- 04/08/2009 - Raptiva Dear Patient Letter (PDF)
- 04/08/2009 - Raptiva Dear Healthcare Professional Letter (PDF)
- 03/13/2009 - Medication Guide for Raptiva (PDF)
- 03/13/2009 - FDA approved Medication Guide for Raptiva
- 02/19/2009 - FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva
- 10/16/2008 - FDA Approves Updated Labeling for Psoriasis Drug Raptiva
Speak to a Lawyer
If you or someone you love is experiencing severe side effects from the use of Raptiva, please contact your doctor immediately for a full evaluation. If you would like to have more information regarding your legal rights, please fill out our free legal evaluation form on the right. Only a little information is required, but the more information you share with our law firm the more detailed our answers will be in addressing your specific concerns. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.
