Xeljanz Lawsuit

Xeljanz FDA Safety Clinical Trial Timeline

February 25, 2019: The FDA issues a statement alerting the public that an ongoing safety clinical trial found an increase in blood clots in the lungs and an increase in death in patients taking the 10 mg twice daily dose of Xeljanz. The agency’s statement advises patients taking Xeljanz to be alert for symptoms of blood clots in the lungs and recommended patients to continue taking Xeljanz until they consult their healthcare provider.

July 26, 2019: The FDA issues a Black Box Warning for the 10 mg twice daily dose of Xeljanz, citing an increased risk of blood clots in the lungs and death. The warning limits the use of Xeljanz in treating ulcerative colitis to patients who are not treated effectively with other medications. As a result of this warning, the FDA discontinues the evaluation of the 10 mg twice daily dose of Xeljanz in its ongoing safety clinical trial and switches participants taking the 10 mg dose to the 5 mg dose.

February 4, 2021: The FDA announces that initial results of its safety clinical trial show that patients taking Xeljanz are at a higher risk of heart-related problems and cancer than patients taking a TNF inhibitor. The announcement states that final results of the trial are not yet available, but adds that the agency will evaluate the results and communicate final conclusions once its evaluation is complete. The agency recommends patients currently taking Xeljanz consult their healthcare provider with any questions or concerns.

How Do Xeljanz and Xeljanz XR Work?

Xeljanz is the brand name drug manufactured by Pfizer to treat rheumatoid arthritis. It is made from the active ingredient tofacitinib and was approved by the U.S. Food and Drug Administration (FDA) to treat rheumatoid arthritis in November 2012, psoriatic arthritis in December 2017, and ulcerative colitis in May 2018. Xeljanz XR is the extended-release version of the medication.

Xeljanz and Xeljanz XR work by slowing down Janus kinase (JAK) enzymes. These enzymes are responsible for DNA transcription which triggers cell growth. If there are problems in this process, unwanted tissue growth in the joints can occur. The tissue can then harm the bone structure and cartilage that are immensely important for joint function, and the extra tissue can cause inflammation and pain which is compounded when the body’s immune system attacks the tissue. The result of this inflammation and pain is rheumatoid arthritis. 

Xeljanz is intended to slow down JAK enzymes thereby preventing this chain of events and treating rheumatoid arthritis.

Xeljanz Dosing and Administration

Xeljanz is mostly commonly administered orally, in pill form.

Two Types of Xeljanz Medication: 

• Xeljanz– the standard medication that comes in 5 mg and 10 mg doses 
• Xeljanz XR– the extended release version of Xeljanz which comes in 11 mg pills that delay the release of the medication throughout the day 

On July 26, 2019, the U.S. Food and Drug Administration (FDA) announced a Black Box Warning for Xeljanz 10 mg twice daily due to the increased risk of blood clots and death. As a result, the FDA recommended that Xeljanz be reserved for patients with ulcerative colitis whose condition is not being effectively treated with tumor necrosis factor (TNF) blockers. 

FDA Xeljanz Recommendations

The FDA instructed patients to not stop taking Xeljanz without discussing it with their medical provider. Healthcare providers were advised to weigh the risks and benefits when deciding whether to prescribe or continuing patients on Xeljanz. 

The current Xeljanz recommendations are based on preliminary results from a clinical study; the final results have yet to be released. The FDA said that it is working with Xeljanz’s manufacturer, Pfizer, to review the final results as they become available. 

Serious complications from Xeljanz can include: 

• Heart attacks
• Strokes
• Cancer
• Blood clots, including pulmonary embolism, deep vein thrombosis, and arterial thrombosis
• Death