The U.S. Food and Drug Administration (FDA) is warning the public that the immune-suppressing and anticancer drug rituximab—sold under the brand name Rituxan—might reactivate hepatitis B infections.
What Is Rituxan and What Is It Prescribed For?
Rituxan is the brand name for the drug rituximab. It is manufactured by Genentech, Inc., a subsidiary of Swiss pharmaceutical giant Hoffmann-La Roche, but it is co-marketed with Biogen Idec., Inc. This prescription medication is used to treat chronic lymphocytic leukemia (CLL), Non-Hodgkin’s Lymphoma, Rheumatoid Arthritis, Granulomatosis with Polyangiitis (Wegener’s Granulomatosis), and Microscopic Polyangiitis. The FDA approved the drug in 1997 as an intravenous injectable.
CLL is the most common type of leukemia, and it occurs when B-cell lymphocytes grow out of control in the bone marrow and blood stream. B-cell lymphocytes contain an antigen called B-lymphocyte antigen CD20 (CD20), whose purpose is optimizing B-cell lymphocytes’ ability to attack infections. Rituxan is a chimeric monoclonal antibody that binds to CD20 and in the process kills the cancerous B-cell lymphocyte.
Rituxan Might Reactivate Hepatitis B Infections
On September 25, 2013, the FDA issued a drug safety communication warning the public that it approved changes to Rituxan’s label to include a black box warning, the agency’s most serious kind of alert. The communication also applied to Arzerra, a similar drug to Rituxan. The new label will prominently display information about the possibility that Rituxan can cause the hepatitis B virus to reactivate in users who either had hepatitis B or are carriers for the virus. It is also possible for patients who were never infected with hepatitis B to contract it as well. Adverse side effects of hepatitis B reactivation can include:
- Fulminant hepatitis (acute liver failure)
- Hepatic failure
The agency based its decision to issue the drug safety communication on data collected from its Adverse Event Reporting System database for the time period from November 1997 to August 2012. The FDA identified 106 cases of fatal hepatitis B-related acute liver injuries in Rituxan users. Another three Arzerra users died from the same causes, but that drug has been on the market for a shorter period of time.
The FDA advises health care providers to screen patients for hepatitis B prior to initiating treatment and to discontinue the drug in patients who develop the condition.
Since September 2006, the Rituxan label has also included a boxed warning stating that the drug can cause progressive multifocal leukoencephalopahy (PML). PML is a rare disease caused by the John Cunningham virus, which is common and almost always harmless in humans, but it can attack those with compromised immune systems, such as those of people on immunosuppressants like Rituxan. PML destroys the fatty covering of the brain called myelin, thereby impairing transmission of electrical signals in the brain. Symptoms of this disease include:
- Impaired speech
- Vision loss
- Cognitive deterioration
An MRI can detect PML, but other than blood plasma transfusions to cycle the drug out of the body no effective treatment exists. Patients usually die within four months of being diagnosed.
RLG’s Rituxan Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Rituxan lawsuit on your behalf if necessary. RLG will also keep you up to date on any Rituxan class action lawsuits, additional FDA Rituxan warnings, and Rituxan FDA recall announcements. If you or a loved one has taken Rituxan, and you believe it caused an injury, contact RLG today.