FDA announces new warnings for multiple medications due to heightened risk of heart issues, stroke and death
The FDA has announced that it will be requiring updated warnings for multiple arthritis and ulcerative colitis medications due to an elevated risk of myocardial infarction, stroke, blood clots, cancer and death.
The medications in question are tofacitinib, baricitinib and upadacitinib, which are sold as Xeljanz/Xeljanz XR, Olumiant and Rinvoq, respectively.
The update is largely based off recent data from a trial that compared tofacitinib and tumor necrosis factor (TNF) blockers among rheumatoid arthritis patients. Baricitinib and upadacitinib were not a part of that trial, but they are part of the same drug class—JAK inhibitors—and prescribed for the same reasons.
“We cannot determine how likely it is that someone will experience these side effects when taking Xeljanz/Xeljanz XR, Olumiant, or Rinvoq,” the FDA said in its announcement. “However, if you are a current or past smoker, or have had a heart attack, other heart problems, stroke, or blood clots in the past, you should tell your healthcare professional as these may put you at higher risk for serious problems with these medicines.”
Healthcare providers are asked to reserve the use of these JAK inhibitors “for patients who have had an inadequate response or intolerance to one or more TNF blockers.”
Two additional JAK inhibitors, ruxolitinib (Jakafi) and fedratinib (Inrebic), are not included in this advisory. They are prescribed to treat blood disorders, the FDA explained, and ‘require different updates to their prescribing information.”
Read the full FDA announcement here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.