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The agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns

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Other reported effects Beyond GI symptoms, clinical trials noted several other effects worth monitoring: Increased heart rate: A small, dose-dependent increase in resting heart rate was observed, consistent with what occurs with other GLP-1 agonists