In July of 2019, the Food and Drug Administration (FDA) approved a new boxed warning for Xeljanz and Xeljanz XR regarding the risks of blood clots and potential death for users of the drug. Manufacturers of Xeljanz were previously made aware that the use of the drug at higher doses could result in serious health complications. However, these manufacturers failed to warn the public of the dangers.
What does Xeljanz do?
Xeljanz, also known as tofacitinib, is used to treat moderate to severe rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis. Xeljanz works by blocking the enzymes in the body that cause inflammation. It was approved by the FDA in 2012 at a dose of 5 mg twice per day. Many patients began taking 10 mg twice daily. When manufacturer Pfizer asked for approval of this higher dosage, the FDA required a post-marketing study to test its safety.
Data from this study indicated that the use of Xeljanz placed patients at a higher risk of developing blood clots. Blood clots that break loose and enter the lungs of a patient can cause a pulmonary embolism, which can lead to death. Xeljanz did not warn consumers of this potential side effect, and therefore, patients and medical professionals were unable to make informed decisions about whether to use the drug.
Did Pfizer Know of the Safety Issues?
There is evidence that Pfizer knew that Xeljanz was unsafe at higher dosages prior to the post-marketing study. In 2013, tests conducted in Europe found that there were a number of dangerous side-effects present with the use of a 10 mg twice daily dose of Xeljanz. These side-effects included blood clots and pulmonary embolism. The European Medicines Agency denied approval for the marketing of the drug. Yet Pfizer failed to warn American consumers of this danger.
While the FDA is now requiring a “black box warning” advising consumers that the use of Xeljanz and Xeljanz XR can lead to serious injury or death, consumers have been using the product for years. The clinical study regarding the use of Xeljanz at the higher dose is still ongoing, but the warnings were clearly necessary as multiple cases of blood clots and pulmonary embolism were discovered.
Contact a Product Liability Attorney
If you suffered from blood clots after using Xeljanz, you should have a product liability attorney evaluate your case. At Gregg M. Goldfarb, LLP, we have helped hundreds of clients injured by defective products. Contact us online or call us at (305) 374-7000 to schedule a free consultation.