Is compounded Glucagon-like peptide (GLP) for weight loss FDA approved?

Compounded GLP-1 Medications for Weight Loss Are Not FDA Approved

Compounded glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for weight loss are not FDA approved and should not be used for weight management. 1 Only specific, commercially manufactured GLP-1 RAs such as semaglutide (Wegovy) and liraglutide (Saxenda) at specific doses have received FDA approval for weight management.

FDA-Approved GLP-1 RAs for Weight Loss

The FDA has approved only the following GLP-1 RAs for weight management:

1. Semaglutide (Wegovy): Approved in 2021 at a dose of 2.4 mg weekly 1
2. Liraglutide (Saxenda): Approved at a dose of 3.0 mg daily 1
3. Tirzepatide (Zepbound): Most recently approved dual GIP/GLP-1 receptor agonist

Why Compounded GLP-1 RAs Are Problematic

Compounded medications pose several significant concerns:

• No FDA quality control: Compounded products lack the rigorous manufacturing standards and quality controls required for FDA-approved medications
• Unknown efficacy: The specific doses and formulations in compounded products have not been validated in clinical trials
• Safety concerns: The safety profile of compounded GLP-1 RAs has not been established through proper clinical testing
• Variable potency: Compounded products may have inconsistent concentrations and bioavailability

Efficacy of FDA-Approved GLP-1 RAs

FDA-approved GLP-1 RAs have demonstrated significant efficacy for weight loss:

• Semaglutide: Produces 10.76% total body weight loss (TBWL) on average, with weight loss ranging from 9.7 to 16.8 kg 1
• Liraglutide: Achieves approximately 3.6% weight loss compared to placebo 1
• Tirzepatide: Most effective with mean weight loss of up to 21% at 72 weeks 1, 2

Safety Considerations for GLP-1 RAs

FDA-approved GLP-1 RAs have established safety profiles with known contraindications:

• Contraindicated in: Patients with personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 1
• Common adverse effects: Nausea (8%), diarrhea (9%), constipation (5%), vomiting (4%) 1
• Monitoring needed for: Signs/symptoms of pancreatitis or gallbladder disorders 1
• Special populations: Not recommended during pregnancy or lactation 1

Algorithm for Appropriate Weight Loss Medication Selection

For patients seeking weight loss medication:

1. Confirm eligibility:

   • BMI ≥30 kg/m² or
   • BMI ≥27 kg/m² with at least one weight-related comorbidity

2. Screen for contraindications:

   • Personal/family history of medullary thyroid cancer
   • Multiple endocrine neoplasia syndrome type 2
   • Pregnancy or breastfeeding
   • History of pancreatitis

3. Select FDA-approved medication based on:

   • Desired weight loss target
   • Comorbidities (especially diabetes)
   • Administration preference (daily vs. weekly)
   • Insurance coverage/cost considerations

4. Combine with lifestyle interventions:

   • Reduced caloric intake
   • Increased physical activity
   • Behavioral support

Common Pitfalls to Avoid

• Using compounded products: Despite potential cost savings, these lack FDA approval and quality control
• Inadequate dose titration: Proper titration is essential to minimize gastrointestinal side effects
• Unrealistic expectations: Weight regain is common if medication is discontinued
• Neglecting lifestyle changes: GLP-1 RAs work best when combined with diet and exercise
• Overlooking contraindications: Careful screening for contraindications is essential

Additional Considerations

• Monitoring: Regular follow-up is needed to assess efficacy and adverse effects
• Duration: These medications are intended for long-term use in chronic weight management
• Discontinuation: Consider stopping if <5% weight loss is achieved after 12 weeks on the maximum tolerated dose

In conclusion, while FDA-approved GLP-1 RAs represent a significant advance in obesity treatment, compounded versions lack FDA approval and should be avoided in favor of properly tested and regulated medications.