Patients taking Xeljanz for ulcerative colitis should be aware of new warnings about an increased risk of blood clots, and even death.

People who suffer from ulcerative colitis, a chronic condition in which the lining of the colon becomes inflamed and leaky, may benefit from taking Xeljanz to manage their condition. According to a research team at the University of California, Riverside, Xeljanz may repair defects caused by this inflammation.

Ulcerative colitis affects approximately 1 million Americans, and is characterized by symptoms including diarrhea, abdominal pain, rectal bleeding, and fatigue. The condition causes intestinal permeability, or a failure of the lining of the intestines to keep out bacteria, and to keep in nutrients and water. When the lining of the intestines is operating correctly, it keeps out toxins, pathogens, and antigens, while still allowing the absorption of nutrients. In ulcerative colitis, this barrier is easily permeable. This permeability and leakage triggers the body’s immune response, and results in fluid loss and diarrhea.

However, according to the recent research from the University of California, Riverside, tofacitinib or Xeljanz may repair this leakage and reduce the damage caused by ulcerative colitis. Declan McCole, a professor of biomedical sciences and the lead author of the study, said the researech team”found tofacitinib fixes the leakiness in the intestinal barrier.” In addition to reducing the symptoms of the condition, Xeljanz may actually repair the damaged tissue. However, while Xeljanz may help people with ulcerative colitis to manage the chronic condition, the drug has also been associated with negative and dangerous side effects, including an increased risk of blood clots.

When Did the FDA Approve Xeljanz for Treating Ulcerative Colitis?

In 2012, the U.S. Food and Drug Administration (FDA) approved Pfizer’s Xeljanz (tofacitinib) to treat arthritis, and in 2018 the drug received additional FDA approval for the treatment of moderate to severe cases of ulcerative colitis.

What Is the Typical Dosage?

Xeljanz is a tablet taken orally, usually twice a day in 5 milligram or 10 milligram dosages. In most patients taking Xeljanz for ulcerative colitis, the doctor prescribes 10 milligrams twice a day for the first eight weeks of treatment. Depending on how the patient responds to the medication, the doctor may keep the patient on 10 milligrams twice a day, or reduce the dose to five milligrams twice a day.

How Does the FDA Know There’s an Increased Risk of Blood Clots?

Patients taking Xeljanz for rheumatoid arthritis participated in a clinical trial to see if higher doses would help them. The trial’s results showed that rheumatoid arthritis patients taking 10 milligrams, twice a day had a higher risk of developing a blood clot in the lungs, a potentially fatal condition known as a pulmonary embolism.

The clinical trial was part of an ongoing post-marketing safety trial run by Pfizer. The results prompted the FDA to add its most serious alert, a black box warning, to Xeljanz. The FDA said the 10 milligram dose is only approved for patients with ulcerative colitis, but warned that the increased risk of blood clots, and of death, applied to them, too.

The FDA quickly followed up by saying Xeljanz should not be provided as a first-line option to treat ulcerative colitis.

“The approved use of tofacitinib [Xeljanz] for ulcerative colitis will be limited to certain patients who are not treated effectively or experience severe side effects with other medicines called tumor necrosis factor (TNF) blockers.”

How Does Xeljanz Work on Ulcerative Colitis?

Xeljanz is a JAK inhibitor, which works by suppressing the part of the immune system that causes inflammation. The JAK signaling pathway located inside cells is responsible for inducing inflammation. Xeljanz blocks the inflammation by blocking the pathway.

Why Does Xeljanz Cause an Increased Risk of Pulmonary Embolism and Death?

Why Xeljanz at 10 milligrams twice a day is linked to a higher risk of pulmonary embolism and death has not been determined, but because the drug suppresses the immune system, patients taking Xeljanz may be more susceptible to infections and to infectious diseases, according to WebMD.

How Would I Know I Have a Blood Clot?

Symptoms of a blood clot can include a sudden shortness of breath or chest pain that hurts more when taking a breath if it’s already gone to the lungs. Usually, a blood clot will start in the lower extremities and travel to the lungs, so any swelling of a leg, leg pain or discoloration in the skin on a leg should be taken as a potential early indication of a blood clot.

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This article is not legal advice. It is presented 
for informational purposes only.