Drug Safety Developments

Neb. man sues makers of Rituxan after infection

Quoted from http://www.google.com/hostednews/ap/article/ALeqM5jjaVp6V9RAWYsijtXGqqRaxyFEvgD9HHIP4O1

Neb. man sues makers of Rituxan after infection

By TIMBERLY ROSS (AP) – August 12, 2010

OMAHA, Neb. — An Omaha man who contracted an infection that rendered him a quadriplegic after taking the immunosuppressant Rituxan says the drug's makers knew of the risk but didn't warn users right away, according to a federal lawsuit filed Wednesday.

Jesse Peetz, 23, said in court documents that he began taking Rituxan in 2003 for treatment of an autoimmune disorder, but that he hadn't known the drug would make him more susceptible to untreatable infections. In September 2005, he developed a near-fatal viral infection that cost him his motor function.

The lawsuit filed in U.S. District Court in Nebraska claims Genentech Inc. and Biogen Idec were negligent and failed to warn users of Rituxan's dangers until 2007.

Caroline Pecquet, a spokeswoman for South San Francisco, Calif.-based Genentech Inc., said Wednesday that the company is "committed to ethical and legal promotional practices," but declined to comment on the specifics of Peetz's lawsuit.

Pecquet also said 2 million people worldwide have used Rituxan in the 12 years its been on the market.

A message left Wednesday with Cambridge, Mass.-based Biogen Idec wasn't immediately returned.

Rituxan, according to the drug's website, is approved to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis. Its risks include fatal reactions from infusion, kidney failure and serious brain infection.

Peetz was diagnosed with the autoimmune disorder thrombotic thrombocytopenia purpura in 1995, at age 11. According to the lawsuit, by 2003 Genentech and Biogen Idec were marketing Rituxan as an off-label treatment for Peetz' condition, meaning the Food and Drug Administration had not approved it for that use.

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Brain Disease Found in 3rd Patient on Roche’s Rituxan

Quoted from http://www.bloomberg.com/apps/news?pid=20601103&sid=a.soONQKbh5g

Brain Disease Found in 3rd Patient on Roche’s Rituxan

By Rob Waters

Oct. 23 (Bloomberg) -- A third arthritis patient taking Roche Holding AG and Biogen Idec Inc.’s Rituxan developed a rare and potentially fatal brain disorder, U.S. regulators said.

The 73-year-old patient, diagnosed three years ago with rheumatoid arthritis, was treated with Rituxan in February 2009, according to a letter to physicians from Biogen and Roche’s Genentech unit. She developed symptoms four to six months later and was diagnosed with the brain infection known as PML, or progressive multifocal leukoencephalopathy, according to a statement from the U.S. Food and Drug Administration.

The brain disease has been linked to the multiple sclerosis drug Tysabri marketed by Cambridge, Massachusetts-based Biogen and Irish drugmaker Elan Corp. The European Medicines Agency reported today on its Web site that the number of PML cases in Tysabri users has jumped to 23 from 13 disclosed earlier. Two fatal cases of PML have been reported in rheumatoid arthritis patients using Rituxan, which primarily treats blood cancers.

The woman was the first rheumatoid arthritis patient taking Rituxan to have contracted the brain illness who was not previously treated with a type of anti-inflammatory drug called a TNF antagonist. Basel, Switzerland-based Roche and Biogen co- market Rituxan in the U.S.

“The overall reporting incidence of PML in patients with rheumatoid arthritis receiving Rituxan is rare (3 reports in approximately 100,000 rheumatoid arthritis patients that have been exposed),” the companies said in the letter to doctors. “However, the information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.”