Xeljanz Cancer and Heart Risks Highlighted In Study Data
While the lawyers at Saiontz & Kirk, P.A. are continuing to investigate potential Xeljanz lawsuits involving individuals who suffered a pulmonary embolism or blood clot injury following use of high doses of the arthritis and ulcerative colitis drug, new warnings issued by the FDA suggest that users may also face an increased risk of certain cancers, as well as heart attacks and other cardiovascular problems.
This new information is continuing to be evaluated to determine whether the drug makers may have failed to warn about a wider range of potential side effects from Xeljanz, including:
- Cancer / Lymphoma
- Heart Attacks
- Pulmonary Embolism
- Deep Vein Thrombosis
- Wrongful Death
To submit information for review by our Xeljanz lawyers involving a cancer diagnosis, heart problem or other injury, request a free consultation and claim evaluation.
Failure to Warn About Xelanz Risks
Xeljanz (tofacitinib) was introduced in 2012, as the first member of a new class of medications known as Janus kinase (JAK) inhibitors, which work in a unique way deep inside the cell to disrupt cellular activities.
Since the medication was approved, it has been aggressively marketed by the drug maker, and quickly grew to become a blockbuster treatment for rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. However, there is increasing evidence that the drug makers failed to adequately warn about serious risks from Xeljanz.
The Xeljanz warning label was updated in 2019, after early data from a study found that use of higher doses increase the risk of a serious and potentially life-threatening blood clot in the lungs, known as pulmonary embolism. However, it now appears that problems with Xeljanz extend beyond blood clots and could impact lower doses as well.
On February 4, 2021, the FDA issued a new drug safety communication, announcing that preliminary results from a clinical trial showed an increased risk of serious heart-related problems and cancer from Xeljanz and Xeljanz XR when compared to use of another type of medication, known as a TNF (tumor necrosis factor) inhibitor):
When FDA first approved [Xeljanz], we required the manufacturer, Pfizer, to conduct a safety clinical trial in patients with RA who were taking methotrexate to evaluate the risk of serious heart-related events, cancer, and infections. The trial studied two doses of [Xeljanz] (5 mg twice daily, which is the approved dosage for RA, and a higher 10 mg twice daily dosage) in comparison to another type of RA medicine called a TNF inhibitor. Patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor. In February 2019 and July 2019, we warned that interim trial results showed an increased risk of blood clots and death with the higher 10 mg twice daily dosage, and as a result, approved a Boxed Warning to the [Xeljanz] prescribing information. The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in RA patients treated with both doses of [Xeljanz] compared to patients treated with a TNF inhibitor. FDA is awaiting additional results from the trial.
At this time, our lawyers are continuing to review and monitor the new data about the potential link between Xeljanz and cancer, as well as heart attacks, strokes and other health problems. However, it important to note that the FDA is reminding users NOT to stop taking Xeljanz without first consulting our health care professionals, as doing so may worsen your condition.
To submit information about heart problems or cancer from Xeljanz, which will be included as part of our evaluation of the potential for litigation over the drug makers’ failure to provide adequate warnings, contact Saiontz & Kirk, P.A. at 1-800-522-0102 or complete our on-line case evaluation form.