Genentech and the FDA have 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). As of June 8, 2009, Raptiva was 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 Facts:

Raptiva was approved in 2003. Raptiva is a made up into a solution for a weekly injection to treat patients suffering from moderate to severe psoriasis. It is in a class of drugs known as biologics.

On February 19, 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.

PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. PML is a brain disease that gets worse over time and can attack many parts of the brain at once. There is no effective treatment for PML.

Usage:

Biologic drugs work by supressing the immune system. This results in an increased risk of infection and cancer. Rare but serious effects have also included blood abnormalities and autoimmune diseases such as lupus. Other side effects are flu-like symptoms and pain and inflammation at the injection site.

Raptiva works by suppressing T-cells in the immune system to keep the body from producing excess skin cells which causes the scaly, build-up of plaques. By suppressing T-cells, Raptiva also increases a patient's susceptibility to infections. Do you or a loved one have a brain infection caused by Raptiva?

Litigation:

Attorneys from across the nation are pursuing cases against Genentech the manufacturer of Raptiva. If you have been injured as a result of taking Raptiva you must act quickly to preserve your right to file a claim.

If you or someone you know developed a serious infection while taking Raptiva, they may be entitled to significant compensation. Contact us today to learn whether you can be compensated.

Make sure to contact our experienced, compassionate, and knowledgeable DrugSettlement.com lawyers by using our contact form.