A new boxed Xeljanz FDA warning for blood clots and death may be relevant to consumers taking the drug for ulcerative colitis.

Xeljanz is a small molecule medication used to treat psoriatic arthritis and rheumatoid arthritis. According to Verywellhealth, the drug works by inhibiting pathways in the cells that play a role in inflammation. Although the drug is often used to treat arthritis, it is also used in the treatment of ulcerative colitis and other autoimmune diseases. Recently, the drug has been touted as a potential treatment for severe COVID-19 cases.

According to the Mayo Clinic, ulcerative colitis is an inflammatory bowel disease that causes inflammation and ulcers in the large intestine (colon). This condition can cause diarrhea, abdominal pain, cramping, rectal bleeding, weight loss, fatigue, and other symptoms. Unfortunately, ulcerative colitis is associated with potentially serious complications including severe gastrointestinal bleeding, a perforated colon, severe dehydration, liver disease, bone loss, and more.

Recently, a new Xeljanz FDA warning was reportedly added to the drug’s label after a post market clinical trial revealed an increased risk of blood clots and death.

The post market Xeljanz trial was ordered by the FDA in 2012 after Xeljanz was approved by the agency to treat rheumatoid arthritis. Although the trial is ongoing, an interim analysis of the trial results is concerning, according to the agency. As of January 2019, the post market study has shown that Xeljanz patients are at an increased risk of both blood clots and death. Further analysis of the study date showed that the drug may also increase the risk of cancer.

There were 19 cases of pulmonary embolisms (blood clots in the lungs) in 3,884 in patients taking Xeljanz. In comparison, there were only 3 cases in 3,982 in patients taking tumor necrosis factors (TNF) blockers.

The risk of death was also significant, according to the interim trial results. There were 45 cases of death from all causes in 3,884 Xeljanz patients. In comparison, there were only 45 cases of death in 3,982 TNF blocker patients.

As a result of these risks, the FDA has approved a new boxed Xeljanz FDA warning for blood clots and death. The boxed warning is the most prominent warning that an FDA can require to be added to a drug’s label. The prominence of the warning ensures that patients, pharmacists, and other medical professionals are aware of severe risks associated with a drug.

The FDA recommends that patients tell their doctors if they have a history of blood clots or heart problems. The FDA also says that consumer should stop taking Xeljanz and “seek medical attention right away” if they experience symptoms of a blood clot, including:

• Sudden shortness of breath
• Chest pain that is worse with breathing
• Swelling of an arm or leg
• Leg pain or tenderness
• Red or discolored skin in a painful or swollen leg or arm

The agency also recommends that healthcare professionals prescribe Xeljanz with caution and adhere to new prescribing guidelines. Considering the risks associated with Xeljanz, the FDA only recommends prescribing the drug for ulcerative colitis if patients have failed or do not tolerate TNF blockers. Even if patients with ulcerative colitis are prescribed Xeljanz, the agency has only approved a 10 mg twice daily dose for initial treatment and limited long term situations.

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This article is not legal advice. It is presented 

for informational purposes only.