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EMA Follows FDA Warning on Xeljanz Blood Clot Risks

Posted 20 March 2019 | By Michael Mezher 

EMA Follows FDA Warning on Xeljanz Blood Clot Risks

The European Medicines Agency (EMA) on Wednesday warned patients and healthcare professionals against exceeding the recommended dose of Pfizer’s rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) due to an increased risk of blood clots forming in the lungs.
EMA’s warning comes less than a month after the US Food and Drug Administration (FDA) issued a similar warning after identifying the risk during an ongoing postmarketing safety study for the drug. In the latest analysis from the study, patients taking 10mg of Xeljanz twice daily, double the approved dose of the drug for RA, had a higher occurrence of blood clots in the lungs and death than patients taking 5mg of the drug twice daily.
In both the US and EU, Xeljanz is also approved to treat ulcerative colitis at a dose of 10mg twice daily. Neither regulator has indicated that there are increased risks for ulcerative colitis patients taking Xeljanz at this dose.
EMA says it is currently reviewing the early results of the postmarketing study, A3921133, and says it will take regulatory action if needed once its review is complete.
“The preliminary results of the study showed the overall incidence of pulmonary embolism to be 5-fold higher in the tofacitinib 10mg twice daily arm of the study compared with the [tumor necrosis factor] TNF inhibitor arm, and approximately 3-fold higher than tofacitinib in other studies across the tofacitinib program,” EMA says.
EMA also says that all-cause mortality in the 10mg twice daily arm in the study was higher than in the 5mg twice daily and TNF-inhibitor arms.
In the meantime, EMA says that doctors should monitor their patients for blood clots in the lungs. Patients are instructed to speak to their doctor before changing their course of Xeljanz and to seek medical help if they experience any symptoms of blood clots in the lungs, such as difficulty breathing, chest or upper back pain or coughing up blood.
EMA also notes that there are other ongoing clinical trials in the EU that include a 10mg twice daily dose of Xeljanz but does not recommend any changes to those studies at this time.


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