FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva
February 19, 2009
The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died. All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.
B R E A K I N G N E W S
Psoriasis Drug Raptiva Recalled
April 8, 2009
Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary recall of Raptiva from the U.S. market. The FDA has issued a statement concerning the Raptiva recall -- FDA Raptiva Recall Statement.
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The FDA is reviewing this latest information. The agency will take appropriate steps to:
- ensure that the risks of Raptiva do not outweigh its benefits;
- that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
- that health care professionals carefully monitor patients for the possible development of PML.
PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.
Psoriasis is a chronic disease, for which a number of effective therapeutic options are available, including four other approved biologic agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin, and methotrexate. Generally, treatment for psoriasis patients involves a rotation of therapies.
In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug's risks.
The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.
Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system. These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient's susceptibility to infections.
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.
