FDA Dear Patient Letter
April 8, 2009
Dear RAPTIVA Patient,
Re: VOLUNTARY U.S. MARKET WITHDRAWAL OF RAPTIVAŽ (efalizumab)
Patient safety is a top priority for Genentech. Since September 2008, Genentech has received 3 reports of progressive multifocal leukoencephalopathy (PML), a serious and almost always fatal brain infection caused by a virus, in patients taking RAPTIVA (efalizumab). Because of the following key aspects of PML and our commitment to safety, Genentech has decided to voluntarily stop selling RAPTIVA.
- Although we believe that there are many psoriasis patients who benefit from RAPTIVA, there is no way to know ahead of time who will get PML.
- There is no treatment or cure for PML. People who do live with PML are severely disabled.
What You Need to Do
- Do not stop your RAPTIVA treatment without first talking to your doctor. Stopping RAPTIVA may lead to serious side effects, such as severe worsening of your psoriasis and, in some cases, has led to hospitalization.
- Call or make an appointment to discuss other psoriasis treatment options with your doctor as soon as possible. Pharmacies will only refill prescriptions until Monday June 8, 2009. It is important that you have enough time to plan a change to another treatment before stopping RAPTIVA.
- For the limited amount of time that you may still be taking RAPTIVA, it is important that you read the Medication Guide that comes with your medication. Before each injection, read the Medication Guide, which explains serious side effects of RAPTIVA. You should discuss these side effects with your doctor.
A copy of the RAPTIVA US Prescribing Information and Medication Guide are included with this letter. This information does not take the place of talking with your doctor about your condition or treatment. Please speak to your doctor about any questions or concerns you may have. Additional information may be periodically available at www.raptiva.com.
Thank you for your prompt attention to this letter.
Sincerely,
Hal Barron, M.D., FACC Senior Vice President, Development Chief Medical Officer Genentech, Inc.
SOURCE: U.S. Food and Drug Administration (FDA)
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.
