The FDA has just finished its comprehensive review of the popular JAK inhibitor Xeljanz, with some new warnings and safety precautions. The JAK inhibitor has been previously approved for Rheumatoid Arthritis (RA), psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. This new data collected shows increased risk for adverse cardiovascular events, blood clots, stroke, and even higher risk of cancer. This comes as disheartening news, as there are several other JAK inhibitors that are now being reviewed. Even the lowest dose of 5mg was still associated with an increased risk of blood clots and death, leading doctors to prescribe other medications before using the class of JAK inhibitors.Â
These new safety findings will require the FDA to place several new warning labels on Xeljanz and Xeljanz XR. Since these findings were less than positive the FDA is rethinking the drug class altogether, including Olumiant and Rinvoq. All three JAK inhibitors have previously been approved for several different inflammatory conditions including RA and UC, but the risks may outweigh the benefits. Since both Olumiant and Rinvoq share very similar mechanisms with Xeljanz they may hold some of the same newfound risks.Â
In this safety trial, the JAK inhibitor was compared to TNF (tumor necrosis factor) blockers for RA patients also on methotrexate. They found that Xeljanz was found to be associated with major adverse cardiovascular events (MACE) including blood clots, cardiovascular death, and stroke, as well as acute myocardial infarction (MI). This occurs when a heart artery becomes blocked and causes a spasm of the muscle with acute clot formation. Overall, compared to TNF blockers, the hazard ratio for taking the popular JAK inhibitor is 1.33 with an increased cancer hazard ratio of 1.48. While these newfound restrictions will apply to Xeljanz and Xeljanz XR they will not apply to Jakafi or Inrebic as these are used for blood disorders and not arthritis or UC.
We can expect to see a slowing of prescribing this class of drugs altogether in the near future. Xeljanz will now more than likely be reserved for those who have previously failed or could not tolerate TNF blockers therapy, to ensure that the rewards outweigh the risks for these particular patients. This is especially true for any patients that are or have been smokers, those with preexisting cardiovascular risks, and those who have had previous cancers particularly melanoma. While these increased risks do call for new warning labels, and perhaps pause to whom they are being prescribed, the JAK inhibitor drug class has also seen positive outcomes in treating different types of arthritis as well as moderate to severe UC. With any hefty medication, there is an increased hazard ratio, the key is to just make sure whatever treatment you are on is right for you. Be your own advocate and discuss your options with your doctor before trying any new medications.
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