EMA im­pos­es for­mal lim­it on Xel­janz pre­scrip­tion as reg­u­la­tors con­tin­ue to re­view safe­ty con­cerns

Three months af­ter Pfiz­er flagged blood clot is­sues and a high­er rate of deaths for rheuma­toid arthri­tis pa­tients tak­ing the 10 mg dose of Xel­janz (to­fac­i­tinib) in a post-mar­ket­ing safe­ty study, the EMA has hand­ed down of­fi­cial re­stric­tions in its use.

The agency’s safe­ty com­mit­tee — phar­ma­covig­i­lance risk as­sess­ment com­mit­tee, or PRAC — is still in the process of re­view­ing the ev­i­dence, but it is alarmed enough to ban pre­scrip­tion of the 10 mg twice dai­ly reg­i­men in any pa­tients with a high risk of blood clots in the lungs. Those who have heart fail­ure, can­cer, a his­to­ry or pre­dis­po­si­tion to blood clots are on the list, as are pa­tients tak­ing hor­mone-based ther­a­pies or prepar­ing/re­cov­er­ing from ma­jor surgery.

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