EMA sounds its own safe­ty alarm for Pfiz­er block­buster, but they’re al­so not forc­ing a lim­it on dos­ing — yet

The Eu­ro­pean Med­i­cines Agency has is­sued a for­mal warn­ing for pa­tients and physi­cians to stick with the rec­om­mend­ed dose of Xel­janz for treat­ing rheuma­toid arthri­tis and to watch out for po­ten­tial­ly lethal blood clots.

Pfiz­er has been be­dev­iled by a clear safe­ty sig­nal on their block­buster JAK in­hibitor, flag­ging the risk of blood clots and death for the twice dai­ly 10 mg dose of Xel­janz, which is au­tho­rized at 5 mg twice a day for RA.

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