FDA Issues Black Box Warnings for Four Arthritis Drugs

Meg Seymour, PhD

The FDA has issued black box warnings for four drugs used to treat different types of arthritis. A black box warning is the FDA’s most serious warning about the risks of a drug or medical device.

Xeljanz and Xeljanz XR are FDA approved to treat rheumatoid arthritis, psoriatic arthritis,  ankylosing spondylitis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. However, a large clinical safety trial has found that the drugs increase the likelihood of serious heart-related problems, such as heart attack or stroke, cancer, blood clots, and death.1 The chances of these health problems are even greater for those ages 50 and over and for current or former smokers.2

Because of the risks, the FDA changed the approval to specify it is only approved for patients who already tried but did not benefit from taking a different type of drug (a tumor necrosis factor blocker) for the same condition.1

Xeljanz and Xeljanz XR are a type of drug called a Janus kinase (JAK) inhibitor. Large safety studies have yet to be done on two other JAK inhibitor drugs, Olumiant and Rinvoq, but the FDA has issued the same black box warning for all four of these drugs because the drugs work similarly to Xeljanz and Xeljanz XR and therefore might have similar risks. FDA is also warning that Olumiant and Rinvoq only be prescribed if patients have previously had no response to a tumor necrosis factor blocker.1

The FDA advises that patients who take or are considering taking Xeljanz, Xeljanz XR, Olumiant, or Rinvoq tell their healthcare providers if they smoke or have a history of smoking, as well as whether they have had a history of heart problems such as heart attack, stroke, or blood clots. That’s important because those patients are more likely to be harmed by those drugs.1

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

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  1. U.S. Food and Drug Administration. 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. December 7, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death
  2. DeFeudis N. Amid safety concerns, FDA grants two new JAK approvals — but with added warnings and a key label change. Endpoint News. https://endpts.com/amid-safety-concerns-fda-grants-two-new-jak-approvals-but-with-added-warnings-and-a-key-label-change/. December 15, 2021.