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Progressive multifocal leukoencephalopathy (PML) is a deadly brain infection associated with the powerful cancer drug Rituximab, marketed as Rituxan, which is approved by the FDA for the treatment of non-Hodgkins lymphoma.

In October 2009, the FDA announced the third wrongful death attributed to Rituxan, but other sources put the actual number of deaths and personal injuries at higher numbers. compiles statistics and information on the benefits and dangers of prescription medications attributed 113 wrongful deaths to Rituxan during the calendar year 2007. PML was just one of the causes of death associated with Rituxan, as well as personal injuries: blindness, lung disease, and gastrointestinal ulcer.

Patients receive Rituxan through IV infusion, and many have had adverse reactions to the injection. Those reactions have resulted in severe dizziness, weakness, nausea, fever, chills, muscle pain, and breathing difficulties.

In May 2009, a study from the Feinberg School of Medicine at Northwestern University linked Rituxan to PML.  The study identified 57 cases of PML, and 51 of those patients died.

Charles Bennett, M.D., the A.C. Buehler Professor in Economics and Aging at the Feinberg School, said, “People may think it’s early Alzheimer’s disease or depression. Many of these patients have cancer and when they die, people assume it’s the cancer that killed them.”

The report from Northwestern described two victims of Rituxan, a 57-year old man from New York and an 83-year old woman from Chicago. In both cases, brain biopsies revealed that PML had literally eaten away their brains.

Rituxan is a member of a class of drugs called monoclonal antibodies, and two other drugs in the class have also caused wrongful deaths and severe personal injuries. In April 2009, Genentech pulled Raptiva from the market because of its links to PML.

Rituxan is an immunosuppressant. It works by decreasing the body’s production of certain white blood cells. That, in turn, makes the body more susceptible to illnesses such as PML, which is caused by the JC Virus. The JC Virus is present in almost everyone, and poses almost no threat to anyone with a healthy immune system.

The FDA has approved Rituxan only for the treatment of non-Hodgkins lymphoma, a type of cancer, and for the treatment of Rheumatoid Arthritis (RA). It has been valuable in the treatment of the cancer, and Dr. Bennett said, “In non-Hodgkin’s lymphoma, it turned out to be a home run. It’s been a magic bullet.” He also said that Rituxan is often the best option for patients with this life-threatening cancer because for those patients, the potential reward may justify the risk.

But even magic bullets frequently miss their targets and cause unintended damage, and doctors have been firing Rituxan at targets other than non-Hodgkin lymphoma and RA. Even though Rituxan carries the FDA’s Black Box warning, which designates it as a potentially deadly drug, many doctors have used it “Off-Label” to treat conditions for which it has not received approval.

Many patients have received Rituxan for lupus, and the first two victims identified by the FDA were patients who were given Rituxan for lupus. The third loss of life reported to the FDA occurred in a patient taking the drug for RA.

Since 2006, tests conducted by Genentech and Biogen, the makers of Rituxan, have conducted research that has concluded that the drug is ineffective against lupus.

For Genentech and Biogen, that’s very disappointing news because every sale of Rituxan means big profits. The drug is extremely expensive. It costs thousands of dollars per treatment, and as the Wall Street Journal reported, it had sales in the US alone of $2.6 billion in 2008.

Rituxan is a deadly drug that doctors should prescribe only in life-threatening cases in which the potential reward at least matches the risk.

Dr. Bennett of Northwestern summed up the approach that medical professionals should adopt toward Rituxan. “This drug isn’t aspirin, and it shouldn’t be given willy-nilly to patients who don’t have a fatal disease.”

If you have suffered injury, or a loved one has suffered injury or a loss of life because of Rituxan, contact our highly skilled dangerous drug attorneys to review all medical records to determine if legal action is merited.

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Richard Alexander