Indiana Accident News

FDA releases national drug warning for Rituxan (Rituximab) users

The Food and Drug Administration has released a medical warning to those taking the drug Rituxan (rituximab). Rituxan is a cancer medication used to sow the spread and growth of certain cancers. It is often used in conjunction with a number of other cancer therapies in order to stall the growth of tumors or progression of cancer around the body.

The pharmaceutical company that makes the drug, Genentech, issued a warning to health care providers, oncologists, rheumatologists, and consumers, explaining the newly discovered danger of this drug in certain patients. The letter gives revisions to how doctors and physicians should be prescribing the medicine.

Specifically, the letter highlighted a case of a man who died of Progressive Multifocal Leukoencephalopathy (PML) after receiving Rituxan in a long-term safety extension study. The man also suffered from rheumatoid arthritis. According to Genentech, the patient in the clinical study developed a JC (human polymavirus) virus inflection a year and a half after he had taken his final dose of Rituxan. Immunosuppression can trigger the JC virus, which most people have been exposed to and which normally does not have dire effects. However, when the JC virus enters the brain, it can have a fatal effect on the nervous system.

Originally, the patient suffered from oropharyngeal cancer that was treated with chemotheraphy and radiation therapy. Following those treatments, he was given a number of drugs to suppress the cancer. Scientists think that the patients RA medications mixed with the drugs caused the JC virus to take hold. Although the Rituxan drug already contains a warning about PML in patients with autoimmune diseases, it did not warn about patients with arthritis.

Finally, the company urged health care professionals to report any serious adverse events associated with the drug by calling their drug safety hotline at 1-888-835-2555.

Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions and progressive multifocal leukoencephalopathy (PML). The side effects of the drug include nausea, trouble breathing, itchiness, light-headedness, fever, chills, muscle pain, chest pain, and sore throat. It can also affect kidney and liver function, especially if patients have Hepatitis B. In general, patients should be watched closely for signs of infection.

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