FDA tacks on new warn­ing to Ab­b­Vie's Rin­voq la­bel as safe­ty frets crimp JAK class

The safe­ty prob­lems that con­tin­ue to plague the JAK class as new da­ta high­light some se­vere side ef­fects are cast­ing a large shad­ow over Ab­b­Vie’s Rin­voq.

As a re­sult of a re­cent read­out high­light­ing ma­jor ad­verse car­diac events (MACE), ma­lig­nan­cy, mor­tal­i­ty and throm­bo­sis with Xel­janz a cou­ple of months ago, Ab­b­Vie put out a no­tice late Fri­day af­ter­noon that the class risks are be­ing added to its la­bel for their ri­val drug, which will now be rel­e­gat­ed to sec­ond-line use.

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