February 04, 2021
2 min read
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FDA warns of increased risk for heart-related issues, cancer linked to Xeljanz

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The FDA has issued a safety alert warning patients and health providers of an increased risk for serious health-related problems and cancer linked to tofacitinib compared with TNF inhibitors among older patients.

As part of the alert, the FDA has recommended that health care professionals consider the benefits and risks associated with tofacitinib (Xeljanz, Pfizer) when making treatment decisions for patients with rheumatoid arthritis or ulcerative colitis. Physicians should continue to follow the recommendations included in the drug’s prescribing information.

U.S. Food and Drug Administration
The FDA has issued a safety alert warning patients and health providers of an increased risk for serious health-related problems and cancer linked to tofacitinib compared with TNF inhibitors. Source: Adobe Stock

However, patients should refrain from discontinuing the drug without first consulting their health professionals, as doing so could worsen their condition, according to the FDA. Patients should talk to their health providers about any questions of concerns they have.

The alert is based on preliminary results from ORAL Surveillance, a post-marketing safety clinical trial required by the FDA to demonstrate non-inferiority of Xeljanz compared to TNF inhibitors among patients with RA with regard to risk for cardiovascular events and malignancies. This trial also investigated other potential risks, including blood clots in the lungs and death.

According to early results, Xeljanz failed to meet the study’s primary endpoint, and was instead associated with a higher rate of major adverse cardiovascular events and malignancies compared with TNF inhibitors among patients aged 50 years and older with underlying cardiovascular risk factors. However, the FDA is still awaiting further results from the trial.

“Providing information on the safe and effective use of our medicines is imperative,” Tamas Koncz, MD, PhD, chief medical officer for Inflammation and Immunology at Pfizer, said in a company release. “We believe that extensive additional analyses of these study data, and communicating them as soon as possible, will further clarify the benefit and risk profile of tofacitinib to help inform medical decision-making and patient care.”

In February and July 2019, the FDA warned that interim trial results demonstrated an increased risk for blood clots and death linked to the higher, 10 mg, twice daily dosage of the drug. As a result, the administration approved a Boxed Warning for tofacitinib’s prescribing information.

The administration approved tofacitinib for adults with RA who did not respond well to methotrexate in 2012. The drug was later approved for patients with psoriatic arthritis who did not respond well to methotrexate or other similar medicines in 2017. One year later, the FDA approved tofacitinib for moderate-to-severe ulcerative colitis.

The FDA is encouraging health providers and patients to report adverse events related to Xeljanz and Xeljanz XR to the administration’s MedWatch Safety Information and Adverse Event Reporting Program.