Rituxan, an immunosuppressant medication, is generally prescribed to treat rheumatoid arthritis, non-Hodgkin’s lymphoma, B cell leukemia and certain autoimmune disorders. The Federal Drug Administration (FDA) approved it in 1997 and by December 2006, the FDA had issued a warning about the risk of progressive multifocal leukoencephalopathy (PML) in patients using Rituxan. Millions of patients have been prescribed Rituxan since its introduction.
Rituxan and Brain Infection Risk
Rituxan works by shutting off a part of the immune system that isn’t functioning properly in patients with autoimmune-related diseases and disorders. However, soon after the drug’s release, the FDA started receiving reports about patients who had developed PML, a rare, life-threatening brain infection.
A report in the May 2009 issue of the journal Blood, shared insights regarding the incidence of PML in patients using Rituxan. The researchers studied all PML-Rituxan case descriptions from 1997 to 2008. The researchers evaluated more than 60 cases. Below are few key statistics from their report.
- Median time from last dosage of Rituxan to being diagnosed with PML was 5.5 months.
- After patients were diagnosed with PML, the average life expectancy was two months.
- The fatality rate in patients who had taken Rituxan and developed PML was 90 percent.
The authors concluded their abstract: “Awareness is needed of the potential for PML among rituximab-treated persons.”
Possible Rituxan Side Effects
As aforementioned, the primary deadly side effect of taking Rituxan is PML, a rare demyelinating disease of the central nervous system. It causes inflammation of the white matter within the brain and typically develops in people who have suppressed immune systems, such as those with HIV, chronic lymphocytic leukemia and Hodgkin's lymphoma.
PML symptoms include the following.
- Vision loss, sleep problems
- Memory failure and mental deterioration
- Muscle weakness, including facial weakness
Many patients who develop Rituxan die within a few months, and if they survive the disease, they may have long-term complications. For instance, one man who developed PML after taking Rituxan for an autoimmune disorder became a quadriplegic as a result of the disease. He sued Genentech and Biogen Idec, for medical damages totaling $75,000, plus additional compensation for pain and suffering and court costs.
Drug Manufacturers Have a Legal Duty
Drug manufacturers have several legal duties by which they must abide.
- Only put reasonably safe products on the market.
- Track and monitor the side effects of their products.
- Put adequate warning labels on their products.
- Be transparent with all the risks their drugs may have.
- Recall any dangerous or tainted products.
- Market them only for uses approved by the FDA.
If they fail to uphold their duties, injured victims can hold the manufacturer accountable by filing a dangerous drug claim. In the aforementioned case, one of the plaintiff’s claims was that the company marketed Rituxan for off-label uses, i.e., for non-FDA approved conditions. This is not only unethical, but also illegal, and in many victims’ cases, devastating.
The man’s attorney noted, “Patients and doctors are forced to trust that pharmaceutical manufacturers will be honest about the risks involved with the drugs being marketed. If the pharmaceutical manufacturers conceal and deceive, the results to the patient can be absolutely devastating."
Consult an Attorney about Legal Options after Infection from Rituxan
If your loved one suffered serious or fatal harm due to the effects of Rituxan treatment, speak to a dangerous drug attorney to determine your legal options. You may be able to file a personal injury claim or wrongful death claim and sue the company for damages.