Fol­low­ing EMA, FDA re­stricts use of high-dose Xel­janz, warn­ing of added risks for the block­buster JAK

The FDA has come out with new re­stric­tions on the use of Pfiz­er’s high-dose ver­sion of Xel­janz af­ter re­searchers drew a di­rect line be­tween the 10 mg dose and a high­er risk of blood clots and death.

In a new safe­ty warn­ing out to­day, the agency added a boxed warn­ing for the block­buster JAK in­hibitor, ad­vis­ing physi­cians of the risk and or­der­ing them to re­strict the ap­proved 10 mg dose for ul­cer­a­tive col­i­tis to “cer­tain pa­tients who are not treat­ed ef­fec­tive­ly or who ex­pe­ri­ence se­vere side ef­fects with cer­tain oth­er med­i­cines.”

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