The Food and Drug Administration (FDA) added a new boxed warning to the drug Xeljanz (tofacitinib) after identifying an increased risk for pulmonary embolism and death with the 10mg twice daily dose, which is the dosage used in patients with ulcerative colitis. The agency is also limiting the use of the drug to certain patients with ulcerative colitis who are not effectively treated with or experience severe side effects with certain other medications.

Xeljanz is also FDA-approved to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA). The higher dose – 10mg twice daily – is not approved for RA or PsA patients, but was previously approved for patients with ulcerative colitis for initial treatment and long-term use in limited situations.

The FDA made the decision to add a boxed warning – the FDA’s most prominent warning – after reviewing interim data from an ongoing safety clinical trial of Xeljanz in patients with RA at a lower and higher dose of medicine. The data showed 19 cases of blood clots in the lungs and 45 cases of death from all causes out of 3,884 patient-years of follow-up in patients who received Xeljanz 10mg twice daily. This was compared to three cases of blood clots in the lungs and 25 cases out of 3,982 patient-years in patients who received TNF blockers.

And while the increased risk of blood clots and death were seen in patients taking the 10 mg of Xeljanz for RA, the risks may apply to patients taking the drug for ulcerative colitis, the FDA said in a safety communication.

Overactive immune systems contribute to RA, PsA and ulcerative colitis. Xeljanz works by decreasing the activity of the immune system. The drug was first approved in 2012 to treat adults with RA who did not respond well to methotrexate.

Patients who take Xeljanz are advised to tell their doctors if they have a history of blood clots or heart problems, and to stop taking the medication and seek emergency medical attention right away if they experience any symptoms that may signal a blood clot such as:

  • Shortness of breath;
  • Chest pain that worsens with breathing;
  • Swelling of a leg or arm;
  • Leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm.

Although medications must go through many tests and clinical trials before being approved for use, often serious health risks often become apparent only after a drug has been aggressively marketed and prescribed to millions of patients. Our team of experienced attorneys represent victims with a wide range of injuries against many different companies that manufacture and market defective pharmaceuticals.

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