FDA Warns Against Counterfeit GLP-1 Drugs
- Meghan Hawley
- 12 minutes ago
- 2 min read
Semaglutide and Tirzepatide were placed on the FDA drug shortage list in 2022 which allowed pharmacists to compound “off-brand” copies. However, these formulations are not put through the same testing by the FDA and now that both have been removed from the drug shortage list more talk about safety is arising.
The compounded and “counterfeit” medications are not reviewed for safety, quality or efficacy. The increase in online pharmacies and telemedicine companies that are selling off-brand drugs has made it difficult to determine which facilities are following safety regulations. Many of these online companies operate outside of the US which makes it difficult to regulate. In a 2019 report from the National Association of Boards of Pharmacy they found 95% of websites that claimed to be selling prescription-only drugs were operating illegally. These operations bring harm to patients and the compounding companies that are operating legally to help meet the demand for many drugs while following FDA regulations. Online pharmacies were also found to have very little health assessment prior to providing the prescription, potentially missing major counter-indications, furthering patient risk.
The compounded drugs are not exactly the same as the originals. There is no guarantee of safety in terms of what the product actually is, who is overseeing the production, and if the combination of vitamins and other medications have been thoroughly studied (most haven’t!). The FDA identified some compounded drugs using salt forms of Semaglutide which is not used in the original formulation and has not been proven safe or effective. They also found issues with the dosing of compounded versions. When researchers bought Semaglutide from six online pharmacies only 3 were actually received and those were not found to be pure and had 29-39% more Semaglutide measured than what was on the label.
The removal of Semaglutide and Tirzepatide from the shortage list means that anyone currently on the FDA approved compounded drugs must transition to the name brand drugs within the timeframe the FDA has approved. This does come with a cost increase. This leads to concern that folks will transition to counterfeit versions of the drugs which are less expensive but are exponentially less safe.
Demand can be improved with better insurance coverage and access to help people achieve safe access to medication. They advise only getting medications through FDA approved and state run pharmacies, don't go to online pharmacies to get medications and if you aren't sure, ask your doctor. The FDA specifically notes that Retatrutide and salt forms of Semaglutide should not be used in compounded forms as they are not found to be safe or effective. You can check to see if a pharmacy is state regulated by using this FDA website Here .
Resources:
Endocrine Today March 2025 Vol23, No3: Supply, safety concerns complicate issue of off-brand GLP-1's written by Michael Monostra.
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