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FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions


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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On September 1, 2021, based on a completed FDA review of a large, randomized safety clinical trial, we have concluded that there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (active ingredient tofacitinib). This trial compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor, or TNF, blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz. A prior DSC based upon earlier results from this trial, reported an increased risk of blood clots and death only seen at the higher dose.

We are requiring new and updated warnings for two other arthritis medicines in the same drug class as Xeljanz, called Janus kinase, or JAK, inhibitors, Olumiant (active ingredient baricitinib) and Rinvoq (active ingredient upadacitinib). Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated. However, since they share mechanisms of action with Xeljanz, FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial.

Two other JAK inhibitors, Jakafi (active ingredient ruxolitinib) and Inrebic (active ingredient fedratinib), are used to treat blood disorders, so they are not a part of the updates being required. 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.

We are requiring revisions to the Boxed Warning for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death. Recommendations for health care professionals will include consideration of the benefits and risks for the individual patient prior to initiating or continuing therapy. This is particularly the case in patients who are current or past smokers, those with other cardiovascular risk factors, those who develop a malignancy, and those with a known malignancy other than a successfully treated nonmelanoma skin cancer. We are also limiting all approved uses to certain patients who have not responded or cannot tolerate one or more TNF blockers.

Changes will also be made to several sections of the prescribing information and to the patient Medication Guide. Health care professionals should counsel patients about the benefits and risks of these medicines and advise them to seek emergency medical attention if they experience signs and symptoms of heart attack, stroke, or blood clot.

Side effects involving Xeljanz, Xeljanz XR, Olumiant, and Rinvoq should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.

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