Drug regulators in the Europe Union have concluded that Xeljanz might increase the risk for dangerous blood clots – pulmonary embolism and deep vein thrombosis — when taken by patients already at heightened risk.
As a result, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is recommending:
The EMA placed temporary restrictions on Xeljanz in May, after preliminary findings from a post-marketing study suggested patients taking the 10mg twice-daily dose were 5-times more likely to suffer a pulmonary embolism compared to those treated with a tumor necrosis factor inhibitor and 3-times more likely compared to those on the 5mg twice-daily Xeljanz protocol. The higher-dose Xeljanz group also had more deaths from all causes compared to the study’s other patient groups.
The PRAC also looked at other available data as part of its subsequent Xeljanz blood clot review.
“All data combined showed that the risk of blood clots was higher in patients taking Xeljanz, especially with the 10 mg twice daily dose and in those being treated for an extended period,” the EMA said in a statement. “Results also showed a further increased risk of serious and fatal infections in patients older than 65 years of age. “
Going forward, Xeljanz’s European lable will include information from the study and will list blood clots as an uncommon side effect occurring in between 1 in 1000 and 1 in 100 patients,
The U.S. Food & Drug Administration (FDA) ordered Pfizer to add a Black Box Warning regarding the potential for Xeljanz blood clots to the product label last July.
The agency also restricted Xeljanz as a second-line treatment for ulcerative colitis patients “who are not treated effectively or who experience severe side effects with certain other medicines.” At the same time, an FDA Drug Safety Communication advised doctors to use the lowest effective Xeljanz dose when treating these patients and limit use of the 10mg twice-daily dose to the shortest duration possible.
Finally, the FDA recommended that doctors avoid prescribing Xeljanz to patients already at high risk for blood clots.
Current Xeljanz patients should let their doctor know if they have a history of blood clots, including pulmonary embolism and deep vein thrombosis. However, they should not stop taking the medication without first consulting their healthcare provider, as doing so could significantly worsen their condition.
All patients should seek immediate medical help if they experience any unusual symptoms, especially those that could signify a Xeljanz blood clot, including: