FDA Issues Safety Communication for Xeljanz

July 26, 2019 – The U.S. FDA has issued a safety communication cautioning that Xeljanz® (tofacitinib) and Xeljanz XR® (tofacitinib), manufactured by Pfizer, may increase the risk of blood clots and death when taken at higher doses. Xeljanz and Xeljanz XR are indicated to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ulcerative colitis (UC).

When it first approved Xeljanx in 2012, the FDA required a post-marketing clinical trial to evaluate the risk of heart-related events, cancer, and infections in patients with RA who were on background methotrexate. The trial is studying Xeljanz given at a dose of 5mg twice daily – the currently approved dose for RA – and a higher 10mg twice-daily dosage, both in comparison to the use of a TNF blocker. Interim analysis of the trial’s results identified an increased occurrence of blood clots and death in patients who received 10mg of Xeljanz twice daily compared to those who received 5mg twice daily or a TNF blocker.

Based on these results, the FDA has issued new warnings about an increased risk of blood clots and death in patients who take 10mg of Xeljanz or Xeljanz XR twice daily. This dose is currently used in patients who have ulcerative colitis. The FDA has also limited approval for use of Xeljanz or Xeljanz XR in patients who have UC to individuals who have not been treated effectively or who have experienced severe side effects with certain other medicines. A black box warning will be added regarding the risk of blood clots and death with Xeljanz and Xeljanz XR 10mg twice daily. Both products already carry black box warnings for the risk of serious infection and malignancy.

The FDA advises patients who are taking Xeljanz or Xeljanz XR to inform their healthcare professionals if they have a history of blood clots or heart problems. Patients should speak to their healthcare providers if they have any questions or concerns about their medication. If they experience any unusual symptoms or symptoms that may signal a blood clot, patients should stop taking Xeljanz or Xeljanz XR immediately and seek emergency medical attention. However, if patients are not experiencing these symptoms, they should not stop taking their medication without first talking to their prescriber, as doing so could cause their condition to worsen.

Healthcare professionals are advised to discontinue Xeljanz or Xeljanz XR in patients who have symptoms of thrombosis (blood clots forming within blood vessels), and promptly evaluate these individuals. The FDA recommends that healthcare professionals counsel patients about the risks and advise patients to seek medical attention immediately if they experience any unusual symptoms, including symptoms of thrombosis. Xeljanz and Xeljanz XR should be avoided in patients who may be at an elevated risk for thrombosis. When treating ulcerative colitis, healthcare professionals should prescribe the lowest effective dose and limit the use of the 10mg twice-daily dosage to the shortest duration needed.

The full safety communication can be viewed online at the FDA’s website. Patients and healthcare providers can report any adverse events or side effects that may be associated with the use of Xeljanz or Xeljanz XR to the FDA’s MedWatch program.