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Overall Safety Profile and Considerations in the USA:** * **FDA Benefit-Risk Assessment:** The FDA approved Zepbound for chronic weight management after determining that, for the specific population indicated (adults meeting BMI/comorbidity criteria) and without contraindications, the demonstrated benefits in weight loss and related health improvements outweigh the known and potential risks, **provided the medication is used as directed under the supervision of a healthcare professional.** * **Medical Supervision is Non-Negotiable:** This medication requires a prescription and ongoing monitoring by a US healthcare provider

1 Reference intakes for the average adult according to VO (EU) 1169/2011 (in %)

Retrieved 24 October 2017

Additionally, insurance coverage for new drugs typically lags by 612 months after approval