Top Class Actions’s website and social media posts use affiliate links. If you make a purchase using such links, we may receive a commission, but it will not result in any additional charges to you. Please review our Affiliate Link Disclosure for more information.
Tofacitinib Overview
Tofacitinib is a drug primarily meant to treat moderate to severe rheumatoid arthritis. It was initially approved by the FDA in November 2012 as an oral pill, and is often sold under the brand names Xeljanz and Xeljanz XR. Tofacitinib works by suppressing the activity of the immune system.
It belongs to a drug class known as Janus kinase (JAK) inhibitors. These drugs prevent inflammation and tissue destruction by inhibiting JAKs, the enzymes that regulate the chemical signaling pathways that control biologic processes including blood formation and inflammatory responses.
These enzymes are found in stem cells in bones and joints, and play a role in the inflammation, pain, and tenderness characterized by rheumatoid arthritis and other inflammatory conditions.
The drug has also been approved by the FDA for the treatment of moderate to severe active ulcerative colitis, a type of inflammatory bowel disease causing sores and ulcers in the digestive tract, as well as psoriatic arthritis. Tofacitinib has been approved for adults, and has not been approved for pediatric use.
Side Effects
Although tofacitinib may help to alleviate the unpleasant symptoms of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, the drug may also cause patients to suffer adverse reactions and side effects, some of which can be serious or life threatening. Possible side effects associated with tofacitinib may include:
- Headache
- Diarrhea
- Increased cholesterol levels
- Urinary tract infections
- Sore throat
- Shingles and other rashes
- Runny nose
- Nasopharyngitis
- Upper respiratory infections
- Dangerous infections that may be fatal
Recalls and Safety Announcements
The FDA has added a black box to the labeling of tofacitinib regarding the increased risk of developing infections that may lead to hospitalization or even death.
Additionally, the FDA has warned that the drug may increase the risk of developing a pulmonary embolism (PE), or a blood clot in the lungs.
There is some evidence that the possible dangerous side effects associated with tofacitinib are related to the dose of the drug. While a 10 mg twice daily dose has been approved by the FDA for the treatment of ulcerative colitis, this high dosage has not been approved for the treatment of rheumatoid arthritis and may lead to an increased risk of infections or PE.
Warning signs of serious adverse reactions related to tofacitinib may include sudden difficulty breathing, shortness of breath, chest pain or back pain, coughing up blood, excessive sweating, and clammy or bluish skin. Patients who experience these symptoms may want to seek medical attention, although patients are discouraged from stopping use of tofacitinib without consulting their doctor first.
Lawsuits and Settlements
Patients who have been harmed by the side effects associated with tofacitinib may be eligible to hire an attorney and file a class action lawsuit against the drug manufacturer and distributor. Patients who file lawsuits regarding tofacitinib side effects may be able to collect compensation for medical expenses, the cost of past and future medical care, injuries, pain and suffering, and other damages.
