People who took Xeljanz or Xeljanz XR for rheumatoid arthritis, psoriatic arthritis or ulcerative colitis and suffered blood clots may be eligible to file a lawsuit against Pfizer Inc. Lawyers began accepting cases after the U.S. Food and Drug Administration announced that a safety trial found an increased risk of blood clots in the lungs and death in people who took a higher dose of the drug to treat rheumatoid arthritis.
Lawyers are currently accepting cases from rheumatoid arthritis, psoriatic arthritis and ulcerative colitis patients who took Xeljanz or Xeljanz XR and suffered a blood clot in the legs, thigh or pelvis, or in the lungs. The medical term for blood clots in the lungs is pulmonary embolism, or PE. Doctors refer to the other type of clots as deep vein thrombosis, or DVT.
The U.S. Food and Drug Administration first approved Xeljanz in 2012 to treat moderately to severely active rheumatoid arthritis. It later approved the drug for ulcerative colitis and psoriatic arthritis.
The drug has been on the market for years, but in February 2019, the FDA released a safety alert about an increased risk of blood clots and death. The agency has since approved a black box warning about the risks.
According to the Xeljanz website, about 132,000 Americans were prescribed the drug between January 2013 and July 2018 to treat rheumatoid arthritis. Many more patients may have been prescribed the medication it to treat ulcerative colitis or psoriatic arthritis. Pfizer reported it made about $1.7 billion off the drug in 2018.
Injury Claims: Blood Clots
After the FDA announced an increased risk of clots with Xeljanz, lawyers began accepting cases on behalf of people who took the drug and suffered from two kinds of blood clots: pulmonary embolisms and deep vein thrombosis.
Between 2013 and 2018, the FDA received reports of 52 DVTs and 79 PEs in patients who took Xeljanz, according to the FDA Adverse Events Reporting System (FAERS) Public Dashboard. Patients in 15 of the cases died.
The limitation of FAERS is that data is self-reported, and there is no way to verify these results. There may also be more cases than were reported.
Pulmonary embolisms are dangerous blood clots that travel to the lungs. People who suffer from PEs may have irregular heartbeat, chest pain and trouble breathing. They may faint or feel lightheaded, or cough up blood. PEs require immediate medical attention.
DVTs may cause pain, swelling, tenderness and redness in the part of the body where the blood clot formed or traveled.
These blood clots can be life threatening. Patients who suffer these symptoms should seek medical attention.
Doctors may treat clots with medication, compression stockings or surgery. Some people may have to be on medications for the rest of their lives to prevent future clots.
Lawsuits against Pfizer may seek compensation for medical bills incurred from DVT or PE treatment.
Clinical Trial Finds Increased Risk of Clots
When the FDA originally approved Xeljanz, it required an additional safety study to gauge the cardiovascular safety of the drug. This post-marketing safety study, called A3921133, is ongoing.
On Feb. 19, 2019, Pfizer announced in a press release that it would transition rheumatoid arthritis study patients who were on 10 mg of tofacitinib twice daily to 5 mg of tofacitinib twice daily. The company made this decision after the tofacitinib Rheumatology Data Safety Monitoring Board flagged a safety problem with the 10 mg twice daily treatment group.
The safety monitoring board found people who had taken 10 mg of tofacitinib twice daily for rheumatoid arthritis had a “statistically and clinically important difference” in the rate of pulmonary embolism and overall death compared to people who had taken 5 mg of tofacitinib twice daily or another drug called a tumor necrosis factor inhibitor.
Despite reports of DVTs and PEs in FAERS from 2013 to 2018, Pfizer said it found no results similar to those in the study.
“Similar results to study A3921133 have not been identified in Pfizer analyses of other tofacitinib RA clinical trials or routine monitoring of post-marketing safety data, including our statistical analyses of the FDA Adverse Event Reporting System database,” Pfizer said in its press release.
On Feb. 25, 2019, the FDA released a safety communication to alert the public that the safety trial found an increased risk of PE and death. Three days later, Pfizer sent a letter advising health care providers of the risk.
In July 2019, the FDA approved a black box warning about an increased risk of blood clots and death in people with RA who are 50 years old or older and have at least one cardiovascular risk factor. Though the data found these risks in people with RA, the agency has said people who use the drug for ulcerative colitis may also be at risk.
Please seek the advice of a medical professional before making health care decisions.