Recently, using compounded peptides for weight loss has gained lots of popularity, so much so that FDA-approved treatments such as Ozempic and Wegovy have been on the Food and Drug Administration’s (FDA) Drug Shortages list. This shortage has caused compounders to be able to prepare compounded versions of these drugs that are not reviewed for safety, effectiveness or quality. Patients need to be aware of these differences in compounded medications. The FDA and Obesity Medicine Association (OMA) have both issued warnings about using compounded versions of the drug semaglutide. Here is what you need to know:
What are compounded peptides?
Compounded peptides refer to customized formulations of peptide-based medications that are prepared by pharmacies. The process involves combining specific peptides according to a patient’s unique needs and prescribing requirements. This is not to be used for mass production, storing on shelfs, marketing or selling.
Why you need to be aware
The FDA recommends that compounding medications go through clinical trial testing before consumption, specifically anti-obesity medications, and their formulas. While compounded medications can play a crucial role in individualized patient care, it is important to understand why compounded peptides are not FDA-approved and they cannot assure that compounded drugs have the same safety, efficacy, and purity of FDA-approved medications that have gone through clinical trial testing.
Why is it not FDA approved?
- Unique customization involved in compounded medications
- Lack of standardized manufacturing processes
- Potential safety concerns
- Absence of a comprehensive regulatory framework at the federal level
To obtain FDA approval, a drug manufacturer must go through a rigorous and costly process that involves conducting extensive pre-clinical and clinical trials to demonstrate its safety and efficacy. This process typically applies to commercially manufactured drugs rather than individually compounded medications.
What should patients know
- Regulatory agencies do not review compounded versions of certain drugs for safety, effectiveness, or quality.
- The FDA has received reports that compounders may be using salt forms of semaglutide, such as, semaglutide sodium and semaglutide acetate, which are different from the FDA-approved semaglutide. The salt forms have not been shown to be safe or effective.
- Patients should not use a compounded drug if an approved drug is available.
- Patients should only obtain medications containing semaglutide with a prescription from a licensed health care provider and a state-licensed pharmacy or facility registered with the FDA.
- If you have been prescribed a compounded semaglutide and want to be sure about the ingredients, ask your pharmacist for a certificate of analysis.
What to do from here
It is very important that you choose a plan that is backed by evidence-based medicine for weight loss. To learn more about the best FDA-approved weight loss options for you, visit ngpg.org/medicalweightloss.