FDA Announces Black Box Warnings for Certain JAK Inhibitors


The move comes amid delays in FDA approvals for multiple JAK inhibitors for the treatment of rheumatic conditions.

This article was originally published on HCPLive.com.

The US Food and Drug Administration (FDA) has announced additional box warnings for certain janus kinase (JAK) inhibitors following a study linking arthritis and ulcerative colitis medicine tofacitinib (Xeljanz and Xeljanz XR, respectively) 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.

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