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The lawsuits involve claims that Ozempic and other GLP-1 receptor agonist drugs, including Wegovy and Mounjaro, caused serious gastrointestinal injuries such as gastroparesis, or stomach paralysis

Your written response and subsequent correspondence are inadequate because you did not provide sufficient details for the Agency to determine whether your actions effectively resolved the existing issues and will prevent similar violations in the future, the FDA added

There are steps to take before beginning supplementation to ensure a smoother transition

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Thus, changes in these biomarkers do not accurately assess real-time brain function since the underlying and established deficits in neuronal functioning are unaffected by their absence