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Side effects of the rheumatoid arthritis and ulcerative colitis drug Xeljanz may result in the development of serious and potentially lethal pulmonary embolism. Lawsuits are being reviewed by lawyers nationwide.
STATUS OF XELJANZ LAWSUITS: Product liability lawyers provide free consultations and case evaluations to determine whether financial compensation may be available through a Xeljanz blood clot lawsuit for individuals who have suffered pulmonary embolism, deep vein thrombosis (DVT), stroke or wrongful death injury that may have been prevented if earlier warnings had been provided.
Following updated FDA warnings issued in February 2021, potential claims are also being reviewed for cancer, heart attacks and other cardiovascular problems following use of Xeljanz.
MANUFACTURER: Pfizer, Inc.
OVERVIEW: Xeljanz (tofacitinib) was approved by the FDA in 2012 for the treatment of rheumatoid arthritis, an autoimmune disorder that causes inflammation of the joints in approximately one percent of the population. The drug was designed to block the activity of certain enzymes in the body that affect immune system function and is commonly used as an alternative for patients who have tried methotrexate and other medications without success.
In December 2017, the FDA approved the use of Xeljanz and Xeljanz XR for the treatment of active psoriatic arthritis (PsA), and then approval was expanded again in May 2018 to include treatment of moderate to severe active ulcerative colitis
BLOOD CLOT RISK: In February 2019, Pfizer warned that preliminary data from ongoing Xeljanz clinical trials indicated patients taking 10 mg daily doses of Xeljanz for the treatment of arthritis faced five times the risk of a pulmonary embolism.
Generally, Xeljanz is only prescribed to arthritis patients at 5 mg per day. However, it is prescribed to ulcerative colitis patients at twice that strength. Some doctors prescribe the more powerful dose to arthritis patients, and it was among that population that the increased risk of blood clot related injuries, specifically pulmonary embolism, has been seen.
The FDA issued a drug safety communication about the risks in late February 2019, and Pfizer said it was re-evaluating dosing recommendations for the drug. In March, the European Medicines Agency (EMA) joined the FDA in warning healthcare professionals about the potential dosing risks.
In July 2019, the FDA finally decided that Pfizer should be required to add a new Xeljanz black box warning, which indicates that the twice daily 10mg dose may increase the risk of blood clots and death.
In another drug safety communication, the agency indicated that the blood clot risks should limit the drug to a second line therapy, where it is only prescribed at the high dose to treat ulcerative colitis when other treatment options are not tolerated or effective.
CANCER AND HEART INJURIES: On February 4, 2021, the FDA issued a safety communication to alert healthcare providers and patients about a preliminary review of the recently completed clinical trials, which suggested that there may also be a link between Xeljanz and cancer, as well as serious heart-related concerns.
Data from a postmarketing clinical trial suggest that users of both 5mg and 10mg doses of Xeljanz had a higher occurrence of serious heart problems and cancer when compared to users treated with a TNF inhibitor, which is a different type of drug used for rheumatoid arthritis (RA).
While the FDA indicates patients should not stop taking Xeljanz without first speaking with their doctors, the agency is reviewing whether additional warnings or restrictions are needed due to the potential cancer and heart risks.
XELJANZ LAWYERS REVIEWING CASES NATIONWIDE: As a result of Pfizer’s failure to thoroughly research and test Xeljanz before putting it on the market, or adequately warn recipients or the medical community of the potential side effects of Xeljanz, settlement benefits may be available.
If warnings and information about the risk of pulmonary embolism from Xeljanz had been provided, many users may have decided to take another drug, and injuries and deaths may have been avoided.