Xeljanz is a popular drug that has been used to treat rheumatoid arthritis since 2012 – and, more recently, ulcerative colitis since 2018. Recently, severe and previously unknown Xeljanz side effects have come to our attention, including blood clots in the lungs (pulmonary embolism), legs (deep vein thrombosis), and arms (arterial thrombosis). These clots can be fatal.


A new black box warning was added to the Xeljanz label in the summer of 2019 – but only after a number of patients landed in the hospital with life-threatening events. Patients over 50 with a past or familial history of cardiovascular health problems are at the highest risk for serious Xeljanz side effects. If you or a loved one were injured after taking the 10 mg twice daily dose of Xeljanz, contact a personal injury lawyer specializing in these cases from Showard Law Firm.


What Is the Link Between Xeljanz and Blood Clots?


Early results from an ongoing clinical trial were reported in January 2019, linking Xeljanz and blood clots. According to the data, 19 Xeljanz patients developed blood clots in the lung out of 3,884 users taking 10 mg of tofacitinib twice daily. By comparison, only 3 people out of 3,982 taking TNF inhibitors suffered blood clots. Given these findings, the FDA required Pfizer to add a new black box warning to alert doctors and their patients of an increased risk of blood clots, embolism, and death with the higher dose of Xeljanz for rheumatoid arthritis and ulcerative colitis.


Xeljanz Pulmonary Embolism


A pulmonary embolism occurs when a blood clot breaks off and lodges in the lungs. While the potential causal connection between Xeljanz and pulmonary embolism isn’t well understood, concerns have been expressed for years. In 2013, the European Medicines Agency refused to approve Xeljanz based on its limited effectiveness and concerns that run the gamut from pulmonary embolism, blood clots, and serious infections, to gastrointestinal perforations, liver damage, and cancer.


Furthermore, Olumiant (baricitinib) – a similar JAK inhibitor drug made by Eli Lilly – gained FDA approval in 2018, but it required a black box warning for malignancy and thrombosis and was only approved for the lower dosage due to safety concerns.


Xeljanz Deaths


Xeljanz users have double the risk of death from any cause compared to patients on TNF inhibitors. Interim analysis of clinical trial data revealed 45 deaths of patients prescribed tofacitinib 10 mg twice daily, compared to 25 deaths in TNF inhibitor users. Based on these results, the 10 mg dosage was discontinued in favor of a 5 mg twice daily dose. Concerns about acute heart failure in Xeljanz patients date back to 2011, prior to the drug’s FDA approval.


Other Xeljanz Side Effects


Common Xeljanz side effects include:


  • Nasopharyngitis viral infections
  • Upper respiratory infections
  • Herpes zoster (shingles) infections
  • Gastroenteritis
  • Diarrhea
  • Nausea
  • Headaches
  • Skin rash


Since 2012, a Xeljanz “black box” warning has alerted patients and doctors to the serious risk for potentially fatal infections caused by bacteria, fungi, or viruses that can spread throughout the body. Patients taking Xeljanz have an increased risk of developing lymphoma, Epstein-Barr, and tuberculosis.


No warnings were included for cardiovascular risks until July 2019. Now users are warned:


“Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT), and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/​XELJANZ XR.  The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day. Blood clots in the lungs have also happened in patients with ulcerative colitis.  Some people have died from these blood clots.”


Patient advocates argue that these warnings are “too little, too late.” Doctors wrote more than 140,000 prescriptions for rheumatoid arthritis between 2012 and 2018, so we are likely to see many more complaints.


Have You Experienced Serious Xeljanz Side Effects?


Patients are advised to contact their healthcare provider right away if they experience blood clot symptoms:


  • Sudden shortness of breath
  • Difficulty breathing
  • Chest pain
  • Cough with pink or red mucus
  • Swelling of an arm or leg
  • Skin discoloration to red or blue
  • Warmth or tenderness in the discolored appendage


If you think you may have been harmed by Xeljanz, it is important to speak with your doctor before discontinuing any medication you are on.


Your next step should be to contact Showard Law Firm to discuss the possibility of filing a Xeljanz lawsuit. We are currently reviewing cases nationwide. If you or a loved one have suffered any of the more serious side effects from Xeljanz, it costs you nothing to obtain a free case review. Our experienced team works on a contingency basis, meaning that we earn no fee for our legal services unless we win. You may be eligible to receive compensation for all related medical expenses, lost wages, and an estimation of pain and suffering.