FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death with Janus Kinase (JAK) inhibitors (tofacitinib, baricitinib and upadacitinib)
FDA is requiring revisions to Boxed Warning, its most prominent warning. Risks/benefits should be considered, particularly in current/past smokers, those with CV risk factors or who develop malignancy (MG) & those with MG other than successfully treated nonmelanoma skin cancer.
Source:
US Food and Drug Administration
SPS commentary:
In UK, myocardial infarction has been added as an uncommon adverse effect to SPC for tofacitinib, as well as warning that due to increased risk of serious infections, myocardial infarction, and malignancies in patients >65 years, tofacitinib should only be used in these patients if no alternatives are available
Pfizer issued a Direct Healthcare Professional Communication in July highlighting that in the A3921133 trial, patients with rheumatoid arthritis, age ≥50 years with ≥1 additional CV risk factor, an increased incidence of MI was seen with tofacitinib vs tumour necrosis factor inhibitors.