Date:
October 4, 2021
Issue #:
1634
Summary:
The FDA has required updates to the boxed warnings
in the labeling of the Janus kinase (JAK) inhibitors
tofacitinib (Xeljanz, Xeljanz XR), baricitinib (Olumiant),
and upadacitinib (Rinvoq) describing increased risks
of major adverse cardiovascular events, malignancy,
thrombosis, and death with their use. The new warnings
were prompted by the results of a postmarketing safety
trial with tofacitinib and were added to the labels of
baricitinib and upadacitinib based on the presumption
of a class effect. The tofacitinib package insert had
contained a boxed warning about an increased risk
of thrombosis and mortality with a dosage of 10 mg
twice daily since 2019, but the new warnings are not
limited by dose.
in the labeling of the Janus kinase (JAK) inhibitors
tofacitinib (Xeljanz, Xeljanz XR), baricitinib (Olumiant),
and upadacitinib (Rinvoq) describing increased risks
of major adverse cardiovascular events, malignancy,
thrombosis, and death with their use. The new warnings
were prompted by the results of a postmarketing safety
trial with tofacitinib and were added to the labels of
baricitinib and upadacitinib based on the presumption
of a class effect. The tofacitinib package insert had
contained a boxed warning about an increased risk
of thrombosis and mortality with a dosage of 10 mg
twice daily since 2019, but the new warnings are not
limited by dose.
