Raptiva Lawsuit

If you have been injured as a result of the dangerous drug Raptiva, you may be eligble for compensation and should contact an attorney who specializes in product liability litigation and dangerous drug litigation against pharmaceutical companies.

On April 8, 2009 Genentech and FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). 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 how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis.

Raptiva History

On October 17th,2008 the FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva. In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.

Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

On February 19th,2009 the FDA issued a Public Health Advisory to notify healthcare professionals of three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva. In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva. 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. The Public Health Advisory provides recommendations for healthcare providers and patients when treatment with this product is considered.

Raptiva Recommendations

• Raptiva increases the risk of PML. Longer, continuous use may further increase this risk.
• vInform patients using Raptiva of the potential risk of developing PML.
• There are no known screening tests that can reliably predict PML or medical interventions that can prevent or treat this disease.
• Monitor patients being treated with Raptiva for the onset of neurologic symptoms. Discontinue Raptiva if PML is suspected.
• Patients treated with Raptiva should be periodically re-evaluated to ensure that the benefit of treatment continues to outweigh the risks. Consideration should be given to use of other approved therapies to control the patients' psoriasis.
• The effects of periodic or intermittent use of Raptiva, or the concomitant use of other immunosuppressant drugs on the risk for PML is not known.
• Be aware that Raptiva increases the risk of developing PML. PML is a disease that is fatal or causes severe disability.
• Talk with their healthcare provider about the benefits and risks of treatment with Raptiva.
• Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes.
• Contact their healthcare provider immediately if they experience these symptoms.
• Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML.

The April 8, 2009 patient notification letter from Genentech in full is below:

April 8, 2009

Dear RAPTIVA Patient,

Re: VOLUNTARY U.S. MARKET WITHDRAWAL OF RAPTIVA® (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.