European regulator enhances warning on JAK blocker safety

31 March 2023

Two years after the US regulator concluded it was necessary to increase label warnings on safety for certain JAK inhibitors, the European Medicines Agency has followed suit.

Safety concerns were prompted by detailed results from Study A3921133, a trial of Pfizer’s (NYSE: PFE) product Xeljanz (tofacitinib).

That trial showed rheumatoid arthritis patients at risk of heart disease were more likely to experience a major cardiovascular problem when taking the therapy.

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