FDA Issues Warning Over Potential Cardiovascular Disease Risk with Tofacitinib


Announced in a statement on September 1, the FDA warning is an update to the FDA Drug Safety Communication issued on February 4, 2021 and the results of a review of a trial that found a serious increased risk of CV-related events with the drug.

This article was originally published on HCPLive.com.

In a follow-up to earlier communications, the US Food and Drug Administration (FDA) announced the arthritis and ulcerative colitis medication tofacitinib (Xeljanz and Xeljanz, respectively) could lead to an increased risk of serious cardiovascular adverse events such as heart attack, stroke, cancer, blood clots, and death.

In a large, randomized clinical trial, tofacitinib was compared to tumor necrosis factor (TNF) blockers and results suggested an increased risk of blood clots and death was observed with the lower dose of Xeljanz, mirroring results reporting in an earlier DSC regarding higher doses of the medicine.

In their September 1 statement, 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.

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