Tofacitinib Linked to Heart-Related Disease, Cancer and Death

September 2, 2021
Armand Butera

Armand Butera is the assistant editor for HCPLive. He attended Fairleigh Dickinson University and graduated with a degree in communications with a concentration in journalism. Prior to graduating, Armand worked as the editor-in-chief of his college newspaper and a radio host for WFDU. He went on to work as a copywriter, freelancer, and human resources assistant before joining HCPLive. In his spare time, he enjoys reading, writing, traveling with his companion and spinning vinyl records. Email him at

The US Food and Drug Association are also requiring new and updated warnings for baricitinib and upadacitinib, 2 other arthritis medicines in the same drug class as tofacitinib.

Today, the US Food and Drug Administration (FDA) announced that arthritis and ulcerative colitis medicine tofacitinib (Xeljanz and Xeljanz, respectively) lead to an increased risk of serious heart-related events such as heart attack, stroke, cancer, blood clots, and death.

In a large, randomized safety clinical trial, tofacitinib was compared to tumor necrosis factor (TNF) blockers, another type of medicine used to treat arthritis.

An increased risk of blood clots and death were reported with the lower dose of Xeljanz, mirroring results reporting in an earlier DSC regarding higher doses of the medicine.

The FDA announced that they are requiring new and updated warnings for baricitinib (Olumiant) and upadacitinib (Rinvoq), 2 other arthritis medicines in the same drug class as tofacitinib.

The 2 medicines have not yet been studied in similar large safety clinical trials like tofacitinib.

Despite this, they share the same mechanisms as tofacitinib, which lead to concerns from the FDA regarding similar risks.

Ruxolitinib (Jakafi) and fedratinib (Inrebic), 2 other JAK inhibitors used to treat blood disorders, are not indicated for the treatment of arthritis or other inflammatory conditions.

As such, they are not privy to the updates being required for the aforementioned drugs.

The FDA noted that further action will be taken if they become aware of any additional safety information or data regarding ruxolitinib or fedratinib that would warrant changes in prescribing information.