The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication (DSC) regarding the arthritis and ulcerative colitis drug Xeljanz (and Xeljanz XR), otherwise known as tofacitinib. After studying the results of a large, randomized safety clinical trial of the medicine, the agency stated there was evidence of “serious heart-related events,” including heart attack, stroke, cancer, blood clots, and death. The FDA further warned that the final trial results also indicated that even lower doses of Xeljanz were linked to a heightened risk of blood clots and death. This finding corrects the agency’s earlier DSC, which warned that these risks only increased with higher doses of the medicine.
Olumiant and Rinvoq Could Have Similar Risks as Xeljanz
Tofactinib belongs to a class of drugs called Janus kinase (JAK) inhibitors, which are used to treat arthritis. The FDA now requires new and updated warnings for other JAK inhibitor arthritis medicines that have the same “mechanisms of action” as Xeljanz. These drugs include Olumiant, also called baricitinib, and Rinvoq, also known as upadacitinib.
Revised Boxed Warning Requirements Speak to Identified Risks
Besides issuing this drug safety communication, the FDA is responding to these known risks by requiring that makers of Xeljanz/Xeljanz XR, Olumiant, and Rinvoq update their Boxed Warnings. A Boxed Warning is already the most serious type of FDA drug warning. With the updates, the drugs’ labels and prescribing information will include information about the risks of serious heart-related events, cancer, blood clots, and death.
Furthermore, medical providers will be asked to weigh the benefits against the risks for each patient before they prescribe or continue therapy using these drugs. The FDA is also limiting approved uses of these medicines to patients who either cannot tolerate one or more tumor necrosis factor (TNF) blockers—another type of drug used to treat arthritis—or for whom these other drugs have not proven effective.
Jakafi and Inrebic Blood Disorder Medicines Excluded From Warning Requirement
The FDA excluded two other JAK inhibitor drugs—Jakafi (ruxolitinib) and Inrebic (fedratinib)—from the new, updated-warning requirements. Although these medicines belong to the same class of drugs, they are used for a different medical purpose (blood disorders), which have different requirements for prescribing information updates. The FDA’s drug safety communication states that the agency will alert the public if new safety information surfaces surrounding the risks of taking these medicines.
What Should Patients Do if They Take Xeljanz, Olumiant, or Rinvoq?
The FDA recommends that patients who take these drugs talk to their health care professionals before starting these medicines. Smokers should alert their doctors of their habit, as they could increase the health risks.
Patients who experience side effects from taking any of these drugs should report them using the FDA’s MedWatch form. This will help the agency stay informed about the effects of these medicines.
Patients should also be aware of the pending lawsuits against Xeljanz maker Pfizer. The mass tort claim alleges that the company defectively designed Xeljanz and failed to warn users and the medical community about the serious side effects of the drug.