Raptiva Recalled
Genentech’s psoriasis drug, Raptiva, is being recalled because of its association with an often-fatal brain disease. The injectable drug will no longer be available in the U.S. after June 8, 2009.
According to a letter Genentech has sent to healthcare providers, Raptiva is being pulled from the U.S. market because three patients treated with the drug died from progressive multifocal leukoencephalopathy (PML). PML is a serious and almost always fatal brain infection caused by a virus. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled. Because the risk/benefit profile for Raptiva has changed, it will be subject to a voluntary, phased withdrawal, Genetech said.
Raptiva was approved by the U.S. Food & Drug Administration (FDA) in 2003 to treat moderate to severe plaque psoriasis. Raptiva works by blocking the activation of certain immune cells called T cells, and the migration of those cells into the skin. However, by suppressing the body’s natural defense system, it can also increase the risk of serious infections, such as PML, and malignancies in patients.
In October 2008, U.S. regulators had already required Genentech to place a Boxed Warning on the Raptiva label regarding the drugs’ risk of PML and other infectious diseases. In February, the FDA warned that Raptiva had been linked to three fatal cases of PML. The agency also said that it had learned of a suspected PML death in a fourth person treated with Raptiva.
