By: Aboutlawsuits

A new study indicates that at least 57 patients being treated with the lymphoma-fighting drug Rituxan have developed a rare brain infection, known as progressive multifocal leukoencephalitis (PML), and the cases have involved a 90% fatality rate.

According to the study, published in the medical journal Blood, Rituxan users were more likely to develop PML brain infections than first thought, finding 22 previously unknown cases between 1998 and 2008. However, doctors who contributed to the report say that there is no clear reason why Rituxan PML infections occur, and note that the side effect is still extremely rare in comparison to the drug’s use.

Rituxan (rituximab) is a chimeric monoclonal antibody drug that causes the immune system to target specific types of cells, such as lumphoma cancer cells, to better help the body fight off the disease. It was approved by the FDA in 1997 for treatment of non-Hodgkin’s lymphoma, as well as rheumatoid arthritis. The drug is made by Genentech Inc. and Biogen Idec Inc., with annual sales of about $2.3 billion.

 By: Dermatology Times

Unlike the multiple sclerosis (MS) drug Tysabri (natalizumab, Biogen Idec), which was pulled from the U.S. market in 2005 for safety reasons, then reintroduced, Raptiva (efalizumab, Genentech) appears permanently shelved, sources say.

Natalizumab has survived despite an association with progressive multifocal leukoencephalopathy (PML), as has Rituxan (rituximab, Genentech), used to treat B-cell lymphoma and many other diseases off-label, observes Craig L. Leonardi, M.D., clinical professor of dermatology, Saint Louis University.

Similarly, "It might have been OK for efalizumab to be around — with a giant warning label and clear-cut informed consent for use in very specific situations," he says. "But the company has the right to stop the distribution and manufacture of the drug at any time."

Genentech was to stop marketing the drug after June 8.

Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. 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 on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.

Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.

Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

The Food and Drug Administration on Thursday confirmed three cases and a possible fourth of progressive multifocal leukoencephalopathy, or PML, which causes swelling of the brain and is usually fatal. The patients had been taking Genentech's once-a-week injection Raptiva, which is used to treat red, scaly skin caused by psoriasis.

Regulators did not say when the deaths occurred.

The FDA in October added its most serious warning to Raptiva, after a 70-year-old patient died from PML while taking the drug.

The agency stressed in a statement posted to its website that patients should be aware of the symptoms of the infection, which include weakness, blurred vision and difficulty speaking. Doctors should likewise monitor patients taking the drug for these signs, the FDA said.

PML is typically seen in patients with weakened immune systems, and previously has been reported in patients taking Rituxan, a blockbuster arthritis and cancer drug marketed by Genentech (DNA) and Biogen Idec.

Calls placed to South San Francisco-based Genentech were not immediately returned Thursday.