Beware of Unapproved and Compounded GLP-1 Drugs for Weight Loss

The U.S. Food and Drug Administration (FDA) is raising serious concerns about the safety of unapproved and compounded versions of GLP-1 receptor agonists, such as semaglutide and tirzepatide, often sought for weight loss. These versions have not undergone the FDA’s rigorous review process for safety, effectiveness, and quality, posing potential risks to patients.

Risks of Unapproved and Compounded Drugs:

Patients are strongly advised to obtain prescriptions from their doctors and fill them at state-licensed pharmacies. The FDA’s BeSafeRx campaign provides resources for safely purchasing prescription medications online. Compounded drugs, while potentially appropriate in limited cases where FDA-approved options are unavailable or unsuitable, are not FDA-approved and thus lack the agency’s safety and quality assurances.

Specific Concerns with Compounded GLP-1 Drugs:

The FDA has identified dosing errors as a significant issue with compounded semaglutide products, leading to adverse events and hospitalizations. These errors stem from patients mismeasuring doses and healthcare professionals’ miscalculations. Additionally, reports indicate patients using compounded semaglutide or tirzepatide at doses exceeding those on FDA-approved drug labels, resulting in severe side effects like nausea, vomiting, and abdominal pain.

Healthcare providers are urged to exercise caution when prescribing compounded GLP-1 drugs and to provide clear instructions on proper dosing and administration. Patients should actively communicate with their healthcare providers or compounders to ensure they understand how to measure and administer their medication correctly.

Important Warnings:

• Retatrutide: This drug cannot be used in compounding under federal law as it is not part of an FDA-approved drug and has not been deemed safe or effective.
• Salt Forms of Semaglutide: The FDA warns against using salt forms of semaglutide, such as semaglutide sodium and acetate, in compounding. These are different active ingredients than those in approved drugs, and their safety and efficacy are unknown.
• Adverse Events: The FDA has received numerous adverse event reports related to compounded semaglutide and tirzepatide, including over 455 reports for semaglutide and over 320 for tirzepatide as of February 28, 2025. Due to underreporting, the actual number of adverse events is likely higher.

Counterfeit and Illegally Marketed Drugs:

The FDA is actively investigating counterfeit Ozempic and has issued warning letters to companies illegally selling unapproved semaglutide and tirzepatide online. These counterfeit and illegally marketed drugs may contain incorrect or harmful ingredients and should be avoided.

Furthermore, the FDA has warned against products falsely labeled “for research purposes” or “not for human consumption” that are being sold directly to consumers with dosing instructions. These products are of unknown quality and pose serious health risks.

Patient Recommendations:

The FDA strongly advises patients to only obtain GLP-1 drugs through legitimate prescriptions from licensed pharmacies and to consult with their healthcare providers about any concerns regarding their medications. Vigilance is crucial when purchasing medications online, and consumers should only buy from state-licensed pharmacies.

Source: Food and Drug Administration