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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