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Increased Risk of Blood Clots in the Lungs & Death Linked to Tofacitinib

  • March 12, 2019
  • KBA Attorneys
  • No Comments

While modern medicine has advanced, not all drugs do what they intend to do. Sometimes the design of a drug is defective and can cause more harm and pain rather than treating the illness. This typically means the drug was poorly designed and led to unreasonable side effects. A defective drug can cause all types of unexpected side effects, including severe injury or death.

One of these drugs was tofacitinib (Xeljanz, Xeljanz XR) and after a safety trial was conducted by the FDA, they found an increased risk of blood clots in the lungs and even death with rheumatoid arthritis (RA) patients who were prescribed a higher dose.

FDA Warning For Tofacitinib

The FDA wants to inform all prescribed patients about the drug Xeljanz and its risk towards blood clots in the lungs and death. When the FDA first approved tofacitinib, they required a clinical trial among patients with RA to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor.

The patients that were tested on were required to be 50 years of age and have a cardiovascular risk. During the analysis, the researchers found an increased production of blood clots in the lungs for those patients who were treated with tofacitinib 10 mg twice daily compared to those patients who were treated with tofacitinib 5 mg twice daily.

Even if a drug is FDA-approved and has cleared all safety and quality control measures, it does not mean that the pharmaceutical manufacturer is not liable if complications do arise once it hits the market and more people start to use it. In some cases, mistakes during the manufacturing process can compromise a drug that would have been safe if it was manufactured correctly. In these cases, the manufacturer may be liable for the injuries to patients.

The growth in prescription medication use has led to an increase in unexpected side effects rather than treatment. Those who are affected by dangerous drugs don’t have to suffer alone. Patients are fighting back against negligent drug makers by filing lawsuits and holding them accountable. If you or someone you know has been the victim of a defective pharmaceutical and would like our help, contact KBA Attorneys immediately so our lawyers can help you get the justice you deserve.


FDA. “Xeljanz, Xeljanz XR (tofacitinib): Safety Communication – Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients”, U.S. Department of Health and Human Services, https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM632016?utm_campaign=FDA%20MedWatch%20Xeljanz%2C%20Xeljanz%20XR%20%28tofacitinib%29%3A%20Safety%20Communication&utm_medium=email&utm_source=Eloqua. Accessed March 12, 2019.