FDA Warns of Cardiac Risks with JAK Inhibitors

The FDA has issued a warning about an increased risk of serious cardiac-related events associated with tofacitinib. 

The FDA based the warning on a randomized clinical trial, which showed an increased risk of serious events including heart attack, stroke, cancer, blood clots, and death. The medication is used for several conditions, including arthritis and ulcerative colitis. In the release, the FDA said it is limiting the approval of the medicine to patients who have not responded to or cannot tolerate one or more TNF blockers. 

Based on the risks found with tofacitinib, the FDA is requiring warnings for JAK inhibitors baricitinib and upadacitinib, which are in the same class of drugs. The FDA noted that the arthritis medications have not been studied in similar large safety trials, so the potential cardiac risks have not been as thoroughly reviewed. 

Patients prescribed these medications are encouraged to tell their providers if they are a past or current smoker or have had previous heart issues, including heart attack, stroke, or blood clots in the past. Providers are encouraged to weigh the potential risks and benefits of the medications before prescribing them to patients. The FDA said providers should advise patients about the potential dangers of cardiac events and explain what they should do if they experience any possible symptoms. 

The warning does not apply to the JAK inhibitors ruxolitinib and fedratinib. However, the FDA noted that these medications are not indicated for arthritis and other inflammatory conditions. 

“If FDA becomes aware of any additional safety information or data that warrants updates to the prescribing information for these medicines, we may take further action and will alert the public,” the FDA said in the release.