In 2019, an FDA-mandated study found that patients taking a twice daily 10mg dose of tofacitinib (known by its brand names Xeljanz and Xeljanz XR) may experience an increased risk of developing blood clots in the lungs. The FDA approved tofacitinib for 5mg twice daily use in 2012 and had only approved the drug for use in 10 mg doses for treatment of ulcerative colitis. However, the study’s results have now prompted the drug’s manufacturer, Pfizer, to recommend patients on the 10mg dose transition to the 5mg dose.

What is Xeljanz (tofacitinib)?

Xeljanz was initially approved by the FDA in 2012 to treat moderate-to-severe forms of rheumatoid arthritis, and has since been approved for treating psoriatic arthritis and ulcerative colitis. It is an immunosuppressant that blocks the activity of Janus kinases enzymes that can affect inflammation in the joints. For sufferers of rheumatoid arthritis, it is prescribed to relieve pain in the joints.

What Did The Study Find?

The Xeljanz study was mandated as part of the FDA’s initial approval of tofacitinib to analyze the risk of cancer, heart-related issues, and infections among patients taking the drug. Participants in the study were all over 50 years old and each had at least one cardiovascular risk factor. The participants were on either the 5mg twice daily dose or the 10mg twice daily dose of Xeljanz and were being compared to a group of similar participants on a tumor necrosis factor (TNF) inhibitor.

Results analyzed in 2019 showed that the use of a 10mg twice daily dose of Xeljanz increased the risk of blood clots in the lungs and death compared to participants on the 5mg twice daily dose and the TNF inhibitor. The study continued beyond this discovery, but the results were concerning enough to prompt the FDA to issue a Safety Announcement in February 2019 warning of blood clots in the lungs as a side effect of use of the 10mg twice daily dose.

2019 FDA Black Box Warning

In July 2019, the FDA issued a Black Box Warning for Xeljanz as a result of the safety clinical trial. The preliminary results showed an increased risk of blood clots and death in patients taking the 10mg twice daily dose of Xeljanz compared to patients taking either the 5mg twice daily dose or the TNF inhibitor. 

In response to these findings, the patients taking the 10mg twice daily dose of Xeljanz were transitioned to the 5mg twice daily dose.

2021 Safety Communication from the FDA

In February 2021, the U.S. Food and Drug Administration (FDA) issued a Safety Communication warning the public that the preliminary results from the completed safety clinical trial showed that rheumatoid arthritis patients taking Xeljanz were at an increased risk of heart-related problems and cancer compared to patients taking another rheumatoid arthritis medication. 

 As of spring 2021, the FDA is currently recommending that patients continue taking Xeljanz as prescribed by their healthcare provider and that patients should speak with their provider if they have questions or concerns. Patients have also been asked to report their Xeljanz side effects to the agency’s MedWatch program.

How Do I Know if This May be Happening to Me?

Speak to your doctor immediately if you have been taking Xeljanz and experienced any of these blood clotting symptoms:

  • Sudden shortness of breath or difficulty breathing
  • Chest pain or pain in your back
  • Coughing up blood
  • Excessive sweating
  • Clammy or bluish colored skin

Is Xeljanz Safe?

That is ultimately a question you should discuss with your medical provider. The FDA announcement is not the first time a government agency has expressed concern over the potential side effects of Xeljanz. In 2013, the Committee for Medicinal Products for Human Use (CHMP) advised the European Medicines Agency (EMA) not to approve use of Xeljanz for treatment of rheumatoid arthritis.

In its refusal recommendation, the CHMP cited “significant and unresolved concerns about the risk and type of serious infections seen with tofacitinib, which are related to the immunosuppressant action of the medicine.” The CHMP also noted risks of additional Xeljanz side effects, including certain cancers, perforations in the gut, liver damage, and increased lipid levels in the blood.

Pfizer requested reconsideration on multiple occasions, and the EMA eventually approved Xeljanz for treatment of rheumatoid arthritis in 2017. EMA approval for treatment of psoriatic arthritis and ulcerative colitis came shortly after. However, the EMA announced its own review of Xeljanz in February 2019 after the FDA announced the findings of increased risk of blood clots among users of the twice daily 10mg dose. The results of the EMA review have yet to be released.

What Should I Do Next?

If you or someone you love has suffered blood clots in the lungs, been diagnosed with cancer, or experienced serious heart-related injury after taking Xeljanz, we want to help you. Contact the defective drug attorneys at GoldenbergLaw for a free evaluation of your case. We have over 30 years of experience litigating complex drug injury cases, let us deliver the Gold standard advocacy you deserve.