Raptiva Side Effects (PML) Lawyers
Our attorneys are providing free consultations and evaluations to patients injured by Raptiva
Keywords: Raptiva Side Effects PML Injury Lymphoma Melanoma Tumor Cancer Attorney Lawyer Lawsuit
On April 8, 2009, the U.S. Food and Drug Administration (FDA) announced that Raptiva would be withdrawn from the market. The announcement followed findings that Raptiva (generically known as efalizumab) poses a risk of causing a serious neurological disease called progressive multifocal leukoencephalopathy, or PML. There is no known effective prevention or treatment for PML.
Raptiva is a weekly injection for adults with plaque psoriasis (a chronic disease causing red, scaly patches on the skin). The drug is manufactured by Genentech and was approved for sale in the U.S. in 2003.
Raptiva suppresses T-cells in the body to reduce psoriasis flare-ups. The suppression of T-cells, however, decreases the function of the immune system and increases susceptibility to infections. PML is caused by a virus that affects the central nervous system, and typically occurs in patients with weakened immune systems. PML leads to an irreversible decline in neurologic function and death.
The FDA "strongly recommends" that patients currently taking Raptiva transition to an alternative therapy.
On October 16, 2008, the FDA advised Genentech that Raptiva's labeling should include a black boxed warning - the FDA's strongest safety warning - to warn of life-threatening infections, including PML. Subsequently, on February 19, 2009, the FDA issued a Public Health Advisory warning patients and doctors of the risk of PML posed by Raptiva. The Advisory was issued after three Raptiva users died from PML. Further guidance was distributed regarding the use of Raptiva in March, and the drug was finally withdrawn from the market on April 8, 2009.
In addition to PML, conditions associated with Raptiva include:
- Anemia
- Pneumonia
- Thrombocytopenia (decrease in blood platelets)
- Viral meningitis
- Cancer (malignant melanoma and non-melanoma skin cancer, lymphomas, non-cutaneous tumors)
Additional information on Raptiva side effects
FDA Withdrawal Statement
European Medicines Agency Suspension of Raptiva
FDA Advisory
Black Boxed Warning
Legal help for victims of Raptiva side effects and injuries
If you or a loved one has suffered side effects or illness from Raptiva, you may have valuable legal rights. For a free and confidential evaluation of your case, please fill out the form to the right or contact attorney Tarik J. Naber at (707) 545-1660 or tnaber@gsoglaw.com.
