The European Medicines Agency (EMA) recently made permanent restrictions to Xeljanz prescribing, similar to those seen with the Xeljanz FDA label changes.

In May, the EMA initiated temporary restrictions, stating that “doctors must not prescribe the 10 mg twice daily dose” of Xeljanz in patients at risk of blood clots. The permanent restrictions are less strict, stating that the 10 mg twice daily maintenance dose of Xeljanz shouldn’t be prescribed to ulcerative colitis patients who are at a high risk of blood clots unless it is the last resort for treatment.

The EMA also recommends that healthcare professionals should be cautious when prescribing the drug in patients at risk for blood clots. Additionally, the EMA says that patients older than 65 should only be prescribed Xeljanz as a last resort due to an increased risk of infection.

“These recommendations follow the Agency’s review of an ongoing study in patients with rheumatoid arthritis and an increased risk of cardiovascular disease, plus data from earlier studies and consultation with experts in the field,” the EMA notes.

“All data combined showed that the risk of blood clots in deep veins and lungs was higher in patients taking Xeljanz, especially the 10 mg twice daily dose, and in those being treated for an extended period.”

Xeljanz FDA Label

Xeljanz (tofacitinib) is a drug that treats rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis by decreasing immune system activity in the body. The drug is available in 5 and 10 mg immediate release tables as well as 11 mg extended release tablets.

Although Xeljanz is associated with side effects such as nasal congestion, sore throat, runny nose, headache, high blood pressure, upper respiratory tract infections, rashes, diarrhea, and more, studies have determined that the drug is associated with an increased risk of blood clots and death.

Interim results from an ongoing trial reportedly showed that the drug is associated with a higher incidence of blood clots and death than TNF blockers, other drugs used to treat ulcerative colitis. There were reportedly 19 cases of blood clots in 3,884 Xeljanz patient years compared to three cases in 3,982 TNF blocker patient years. Similarly, there were 45 deaths from all causes in 3,884 Xeljanz patient years compared to 25 deaths in 3,982 TNF blocker patient years.

These results reportedly prompted a new Xeljanz FDA label in July 2019 with the agency’s most prominent Boxed Warning. The labeling for the drug now warns consumers of the risks for blood clots and deaths. Similar to the recent EMA restrictions, the Xeljanz FDA label was accompanied by the recommendation that the drug only be prescribed to ulcerative colitis patients who were not treated effectively or experienced severe side effects with other medications.

The FDA recommends that patients seek medical attention if they experience symptoms of a blood clot such as sudden shortness of breath, chest pain, swelling of the leg or arm, and other signs. Patients are warned that they should not stop the medication without talking to a doctor first.

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