Risks and Safety Considerations to Discuss With Your Doctor Key risks include cardiovascular effects from both agents, hormonal fluctuations due to rapid weight loss altering SHBG and free testosterone, gastrointestinal side effects, and the unknown combined safety profile of an unlicensed drug alongside a controlled hormone therapy
When data integrity, quality oversight, and aseptic controls fail together, FDA treats the issue as a systemic compliance risk rather than a collection of isolated observations
PMID 37364590
Haines noted that it is still unclear which patients are most likely to lose muscle and how this muscle loss might impact blood sugar control
Writingreview & editing: JL, EJR, SWH, WYL
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