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FDLI Enforcement and Litigation Conference, Jill Furman, Director Office of Compliance, CDER, December 2025

Pharmaceutical Research

The most common side effects were: Nausea Vomiting Diarrhea Constipation Fatigue Abdominal discomfort Early satiety Injection site reactions Increased heart rate in the first 24 weeks, but that returned to normal after 24 weeks

Enforcing BMI qualifications (30+ or 27+ with comorbidities) means they are following medical guidelines rather than prescribing to anyone with a credit card

Warning signs include decreased urination or very dark urine, swelling in your legs, ankles, or feet, significant fatigue and confusion, and persistent nausea