Rituxan (rituximab) is an injectable, monoclonal antibody medication that is used to treat certain types of cancer, such as non- Hodgkin’s lymphoma, and is also used with another treatment called methotrexate to reduce the pain and symptoms of rheumatoid arthritis (RA). Manufactured by Genentech, Rituxan works by selectively increasing specific B-cells in the blood. B-cells–a type of white blood cell found in the immune system–usually help the body fight infection and play an important role in diseases such as RA.
Rituxan is prescribed to treat patients with certain types of cancer (non-Hodgkin’s lymphoma), and for rheumatoid arthritis when other treatments have failed.
Rituxan was approved by the FDA in 2000 for the treatment of non-Hodgkin’s lymphoma (a cancer of the lymph nodes) and rheumatoid arthritis.
Common side effects associated with Rituxan include headache, nausea, facial flushing, and dizziness.
In 2004, Genentech notified healthcare professionals of revisions to the ‘Warnings’ section of the prescribing information due to reports of fulminant (lethal) Hepatitis B virus (HBV) contraction, hepatic failure, and death in some patients with hematologic malignancies from using Rituxan. The FDA also issued a public health advisory on Rituxan after two lupus patients taking the drug reportedly died of a viral brain infection.Both patients developed progressive multifocal leukoencephalopathy (PML), a brain infection caused by a common but usually harmless virus.However, in those who contract PML, the infection is usually fatal, as there are no effective treatments.
Other health complications reported with Rituxan use include hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, kidney failure, and severe mucous membranes/skin reactions.
Rituxan is contraindicated in patients who have a history of hypotension, bronchospasm, and angioedema.
What is Rheumatoid Arthritis?
Rheumatoid arthritis is a chronic, inflammatory type of arthritis that is classified as an autoimmune disease (immune cells attack the body’s own healthy tissues). The joints are primarily affected by rheumatoid arthritis, but there can be systemic effects (i.e. organs) as well. The primary symptoms associated with rheumatoid arthritis include:
- joint pain
- joint swelling or effusion
- joint stiffness
- redness and/or warmth near the joint
- restricted range of motion
Morning stiffness lasting more than an hour, involvement of the small bones of the hands and feet, extreme fatigue, rheumatoid nodules, and symmetrical joint involvement (i.e. both knees not one knee) are all characteristics of rheumatoid arthritis. Approximately 2.1 million people in the United States have rheumatoid arthritis and about 1-2 percent of the world population is affected by rheumatoid arthritis.
What should I tell my doctor before taking Rituxan?
Before beginning treatment with Rituxan, tell your doctor if you:
- Are taking any prescription or nonprescription medicines, vitamins, or herbal supplements
- Have an infection that will not go away or keeps coming back
- Are scheduled to have surgery or receive any vaccinations
- Have heart or lung problems
- Are breast-feeding, pregnant, or planning to become pregnant
- Have had hepatitis B or are a carrier of hepatitis B virus
What safety information has been added to the label of Rituxan?
The warning updates on the label of Rituxan include the following:
- Bowel obstruction (blockage of the small or large intestine) and bowel perforation (development of a hole in the small or large intestine) have been observed in patients receiving Rituxan. Some deaths have occurred in non-Hodgkin’s lymphoma patients who were receiving Rituxan.
- A relationship between Rituxan and these events has not been clearly established.
- The average time for Rituxan patients to develop bowel perforation was 6 days from the start of therapy.
- Patients who experience abdominal pain, especially early in treatment, should contact their physician immediately.
What is the most important safety information I should know about Rituxan?
Serious side effects, some of which could be life threatening, have occurred during and after treatment with Rituxan. Seek immediate medical attention if you experience any of the following:
- Infusion reactions, including hives, swelling, dizziness, blurred vision, drowsiness, headache, cough, wheezing, and breathing difficulties
- Kidney problems, including Tumor Lysis Syndrome (TLS), which is caused by the fast breakdown of certain blood cancers. TLS can cause kidney failure and the need for dialysis treatment
- Severe skin reactions, including painful sores, ulcers, blisters, and peeling skin
What should I do if I think I have been injured as a result of taking Rituxan?
If you or a loved one has experienced any dangerous side effects or health problems from using Rituxan, particularly fulminant (lethal) Hepatitis B virus (HBV) contraction, you should contact your doctor immediately. You should also contact an experienced defective drug litigation attorney to discuss your options and to protect your legal rights.
Can I file a lawsuit if I have suffered damages from taking Rituxan?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Rituxan, you should contact your doctor immediately. You may also wish to contact an experienced Rituxan lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.