CDER tweaks Ozem­pic’s post-mar­ket­ing la­bel to in­clude risk for GI dis­or­der

CDER has added two post-mar­ket­ing caveats to the la­bel of No­vo Nordisk’s block­buster di­a­betes drug Ozem­pic, in­clud­ing a warn­ing for a con­di­tion re­lat­ed to a range of gas­troin­testi­nal symp­toms.

The agency’s lat­est change, pub­lished ear­li­er this week, adds one ad­di­tion to the la­bel’s ad­verse re­ac­tion sec­tion and an­oth­er re­gard­ing drug in­ter­ac­tions.

The side ef­fect-re­lat­ed tweak notes that cas­es of ileus were re­port­ed in pa­tients post-mar­ket­ing. Ileus oc­curs when the mus­cles of the in­testines tem­porar­i­ly stop con­tract­ing as nor­mal, which can lead to bloat­ing, vom­it­ing and cramps.

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