
Some JAK Inhibitors to Carry More Black Box Warnings for Cardiovascular Concerns
It is the third set of warnings for certain Janus kinase (JAK) inhibitors due to the risk of heart attack or stroke, cancer, blood clots, and death.
The FDA this week expanded warnings to some medications in the class of drugs known as
After a review of a large randomized safety clinical trial,
This trial compared tofacitinib with tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis, and results showed an increased risk of blood clots and death with the lower dose of tofacitinib.
In July 2019,
As a result of the latest finding, the FDA said it would require 2 other JAK inhibitors, baricitinib (Olumiant) and upadacitinib (Rinvoq), to carry the same warning. Although these 2 medicines were not studied in a safety trial similar to tofacitinib, the FDA said it considers the risks to be similar due to shared mechanisms of action.
The FDA said 2 other JAK inhibitors, ruxolitinib (Jakafi) and fedratinib (Inrebic), are not indicated for the treatment of arthritis and other inflammatory conditions and are not a part of these updates, but the agency said it may take further action if it other safety information becomes known.
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