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How is Xeljanz Used to Treat Rheumatoid Arthritis?
Xeljanz is an oral prescription medication approved to treat moderately to severely active arthritis, psoriatic arthritis and ulcerative colitis. It also comes in an extended-release formulation (11 mg twice daily dose).
Both formulations contain the active ingredient tofacitinib. The medication belongs to a class of disease modifying antirheumatic drugs known as Janus kinase inhibitors or JAK inhibitors.
The FDA approved Xeljanz in the United States following a clinical trial in 2012. Since its release, the drug has become a blockbuster for Pfizer. In 2018, it brought in about $1.8 billion worldwide.
More than 80 countries approved the medication for the treatment of arthritis. In addition, over 40 countries approved it for the treatment of active psoriatic arthritis (PsA), and 70 countries approved it for the treatment of ulcerative colitis (UC).
Risk of Blood Clots Warning
Despite its popularity, the drug may cause a number of side effects. The increased risks of side effects in patients taking Xeljanz reported most often during the first three months of a rheumatoid arthritis safety trial included cardiac events, heart attacks, upper respiratory tract infection, cold-like symptoms, diarrhea, headache, and high blood pressure.
People who participated in a UC safety trial also reported rashes, Herpes zoster (shingles), and elevated cholesterol levels requiring immediate medical attention.
In September 2021 the FDA concluded: “There is an increased risk of serious heart-related events such as heart attack or stroke, cancer and death with arthritis and ulcerative colitis medicine Xeljanz (active ingredient tofacitinib).” Based on these findings from clinical trials that compared Xeljanz to TNF blockers for rheumatoid arthritis, the FDA required a new, stronger black box warning for the drug.
The FDA notified the public in December 2021 that Xeljanz now carries a warning for safety concerns including serious infections; a higher rate of lymphoma and lung cancers; a higher rate of death, and a higher rate of cardiovascular events (stroke, pulmonary embolism, cardiovascular death and heart attack).
The agency also limited the drug’s use to ra patients who have not responded to or cannot tolerate one or more TNF blockers.
- Blood clots in the lungs
- Pulmonary embolism (PE)
- Deep vein thrombosis (DVT)
- Non-melanoma skin cancer
- Lung cancer
- Other cancers
- Heart attack
- Cardiovascular risk factor
- Major adverse cardiovascular event
- Ulcerative colitis
- Serious infections
- Immune system problems
- Extrapulmonary tuberculosis
- Invasive fungal infections
- Jaundice (yellowing of the eyes and/or skin)
- Breath chest pain
- Sudden shortness of breath
- Skin rash
- Other adverse events
As part of the initial FDA approval for Xeljanz back in 2012, Pfizer was required to conduct a long-term post-market research study. The aim of this post-approval study was to evaluate the potential risks of cardiovascular problems resulting from the drug.
The initial results of this long-term study were provided to the FDA at the beginning of 2019 and they caused major concerns. Specifically, the study found that the higher Xeljanz dose (10 mg twice daily) appeared to cause life-threatening clots in some patients.
See all related dangerous drug lawsuits our attorneys are currently accepting.
Deep Vein Thrombosis Symptoms
- Swelling in the affected leg
- Pain in the leg
- Red or discolored skin on the leg
- A feeling of warmth in the affected leg
Pfizer is now facing a rapidly growing number of lawsuits by users of Xeljanz who suffered clots or similar injuries. All pharmaceutical companies have a duty to fully research the safety of their drugs before they are approved and released. This is particularly true with new types of drugs such as Xeljanz.
Drug companies also have a legal duty to warn about any potential risks, side effects, or health concerns associated with their drug. This is information is often critical because it enables doctors to make informed decisions about drug safety for individual patients.
Lawsuits against Pfizer are alleging that the company breached its duties to the public in several ways:
- Pfizer negligently failed to conduct adequate safety research and testing before getting approval for Xeljanz.
- Pfizer knew that the higher dose of Xeljanz caused blood clots and other problems, but failed to disclose this information.
- Pfizer failed to warn that higher doses of Xeljanz may cause cardiovascular problems.
Most of these allegations appear to be fairly valid and Pfizer will likely be facing serious liability in these cases. The warnings about Xeljanz and blood clots are fairly recent, so not many blood clot lawsuits have been filed against Pfizer at this point.
Pfizer will likely be named in hundreds of lawsuits across the country. As of February 2022, there is still no MDL class action.
Related Article: Xeljanz Class Action Suit
Get a Free Lawsuit Evaluation With Our Xeljanz Attorneys
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in lawsuits. We are handling individual litigation nationwide and currently accepting new blood clot injury and death cases in all 50 states.
Free Lawsuit Evaluation: Again, if you were harmed after taking Xeljanz to treat rheumatoid arthritis, you should contact our attorneys immediately. Xeljanz patients may be entitled to a settlement for medical expenses by filing a lawsuit and our Xeljanz Lawyers can help.