Xeljanz XR is a newer treatment for rheumatoid arthritis and ulcerative colitis, receiving approval from the U.S. Food and Drug Administration (FDA) in late 2012.

The agency approved Xeljanz for rheumatoid arthritis in patients who were not responding to methotrexate, the typical first-line treatment for the disease. Dosing for Xeljanz and Xeljanz XR is 5 mg twice daily. A 10mg twice daily dosage of Xeljanz and Xeljanz XR was approved for the treatment of ulcerative colitis, however patients may be developing blood clots from this dosage, resulting in questions about the medication.

What is Xeljanz XR?

Xeljanz XR is a popular medication typically used to treat moderate to severe rheumatoid arthritis. It’s the first of its kind in the Janus kinase (JAK) inhibitor drug family, which works by disrupting cell activation that occurs in signal pathways, or JAK pathways. In doing this, the drug slows down the effects of rheumatoid arthritis.

What are the side effects of Xeljanz XR?

Patients may experience a range of side effects. Some of the more common ones include upper-respiratory tract infections, headache, diarrhea, nasal congestion, sore throat and high blood pressure. According to WebMD, some patients may experience more serious side effects such as a bacterial infection, pnuemonia, shingles, cellulitis, a blood clot in the lung and more. Patients who experience a severe complication should contact their doctor to report the event immediately.

Can Xeljanz XR cause blood clots?

In February 2019, the FDA issued a safety announcement alerting the public that “a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis.”

The agency warned that patients may face an increased risk of blood clots forming in the lungs when prescribed a higher dose of the medication, specifically the twice daily 10 mg.

At this point, patients taking Xeljanz or Xeljanz XR for rheumatoid arthritis should be vigilant for any signs of blood clots including:

• Chest or Back Pain
• Coughing Up Blood
• Breathing Difficulty
• Excess Sweating
• Shortness of Breath
• Clammy Skin
• Bluish Skin

Blood clots in the lungs can cause a pulmonary embolism (a blockage in one of the pulmonary arteries in the lungs) while blood clots in one or more of the deep veins in the body, usually the legs, can cause a condition known as deep vein thrombosis (DVT). Both pulmonary embolisms and DVT are potentially fatal conditions.

Are Xeljanz and Xeljanz XR safe?

European health officials rejected Xeljanz after concerns about serious complications were cited, including an increased risk of cancer, high blood pressure, infections, liver damage and internal stomach bleeding.

The European Medicines Agency stated that there have been no studies indicating that Xeljanz or Xeljanz XR provide any benefits over other rheumatoid arthritis medications, while still carrying the risk of serious side effects.

The FDA required Xeljanz and Xeljanz XR manufacturer Pfizer to conduct a safety clinical trial to evaluate the safety profile of different doses of its drug. This was done by observing patients taking both the 5 mg twice daily and 10 mg twice daily doses. The clinical trial reportedly found that patients faced a higher risk of blood clots when taking the 10 mg twice daily dose.

The FDA further stated that Pfizer will continue this clinical trial through 2019 to complete the drug’s safety evaluation.

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