Furthermore, if you are planning pregnancy, discover you are pregnant, or are breastfeeding, you must discuss Mounjaro use with your healthcare provider immediately, as the safety profile in these situations has not been fully established and treatment decisions require careful consideration of risks and benefits
4,7 In this regard, this addition ensures a more comprehensive discussion aligned with current expert consensus on risk mitigation strategies
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As of July 2026, the FDA's 503B exclusion is still a proposal