FDA Says Safety Trial Linked Xeljanz to Blood Clot Risk

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The U.S. Food and Drug Administration recently announced that a clinical trial has established a link between Xeljanz and blood clots.

In the announcement issued on Feb. 25, 2019, the FDA warned that those taking the prescription medication at higher doses for the treatment of rheumatoid arthritis (RA) may be at risk for blood clots in the lungs, pulmonary embolism, deep vein thrombosis and even death.

The agency warned of the risk in those taking 10 mg of the medication twice daily.

“During the most recent analysis of the trial, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor,” noted the FDA.

Those taking Xeljanz or Xeljanz XR and experience shortness of breath, chest or back pain, excessive sweating, bluish or clammy skin, or coughing up blood should seek medical help immediately.

Xeljanz and Xeljanz XR, generically known as tofacitinib, is made by Pfizer and was approved by the FDA in 2012 for the treatment of RA. It was later approved to treat psoriatic arthritis in 2017 and ulcerative colitis in 2018.

According to the FDA announcement, Xeljanz works by suppressing immune system activity in RA patients.

Upon approval, the FDA required Pfizer to conduct a safety clinical trial to further evaluate the drug.

According to the agency’s safety announcement, there is indeed some concern about increased risks faced by patients taking Xeljanz.

“In this ongoing safety trial required by FDA when it approved tofacitinib for RA, the drug manufacturer, Pfizer, is transitioning patients who were on the high 10 mg twice daily dose to the lower, currently approved dose of 5 mg twice daily,” notes the agency’s announcement.

“This trial will continue and is expected to be completed by the end of 2019. We are working with the manufacturer to evaluate other currently available safety information for tofacitinib and will update the public with any new information based on our ongoing review.”

Rheumatoid arthritis is an autoimmune disease that usually affects the joints, but can also affect the eyes, blood vessels, heart, and lungs.

Xeljanz was seen as another option for RA patients who were not responding to treatment. According to Healthline, the drug maker is set to make more than $18 billion from the drug over the next four years.

The drug is not available in Europe, however, after its health authority found that the medication presented increased risks of high blood pressure, cancer, severe infections, and liver damage, along with gastrointestinal bleeding.

“Patients should not stop or change your dose of [Xeljanz] without first talking to your health care professional, as doing so may worsen your condition. Patients taking tofacitinib should seek medical attention immediately if you experience symptoms of a blood clot in your lungs or other unusual symptoms,” warns the FDA announcement regarding the Xeljanz blood clot risk.