FDA Warns Against Compounded Semaglutide for Diabetes, Weight Loss
Key takeaways:
- The FDA has recently issued warnings to companies offering compounded medications with false or misleading claims that their medications are FDA-approved and equivalent in safety to approved drugs like Ozempic.
- Compounded drugs are created by combining or altering ingredients to customize medications for specific individuals. While compounded drugs are sometimes prescribed by healthcare providers for people who can't afford or access a certain drug, they are not FDA-approved.
- The FDA previously issued an alert to healthcare providers, compound pharmacies, and patients about recent overdoses associated with compounded injectable semaglutide.
Popular diabetes and weight management medications like Ozempic, Wegovy, and Rybelsus have been in and out of shortage and can be costly for people paying out-of-pocket. As a result, some people have turned to compounding versions, which are not approved by the FDA.
While compounded drugs are sometimes prescribed for those who have unique needs or can't access brand-name drugs, it's important to know that these medications are not FDA-approved, meaning they are not reviewed for safety or efficacy before being marketed. Many companies selling these medications have recently been issued warnings by the FDA for false advertising claims.
In addition, these off-label versions could potentially be unsafe. The FDA has previously alerted healthcare providers, compounders, and patients about the dangers of miscalculating dosage when administering injectable semaglutide.
FDA warns of dosing errors with compounded injectable semaglutide
In July 2024, the FDA warned that patient inexperience with measuring and self-administering injectable compound semaglutide products has led to five to 20 times more than the intended dose of semaglutide.
“Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams, and units) may have contributed to dosing errors,” the FDA said.
In the past, the FDA has also mentioned adverse events associated with some forms of unapproved semaglutide. In particular, officials have called out versions that may contain ingredients that are similar to the active ingredient semaglutide but chemically different because they are in salt form. The agency cautioned that it does not review these versions for safety or efficacy. To prevent challenges with dosing errors and overdoses, the FDA encourages people to talk with their healthcare provider to clarify how to measure and administer correct doses with a syringe.
What is compounded semaglutide?
Compounded drugs are created by combining or altering ingredients to make medications tailored to the needs of a specific individual. When the FDA’s drug shortage website lists a drug as “currently in shortage,” compound pharmacies are permitted to buy semaglutide from pharmaceutical ingredient manufacturers, mix it with other ingredients, and prepare a version of the drug – if certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act are met. The FDA doesn’t review these versions for safety, effectiveness, or quality, however.
Some pharmacies have been dispensing versions of the medication made with a different active ingredient called semaglutide sodium. The FDA has called out these versions in particular as potentially unsafe.
“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be salt formulations,” the FDA wrote. “Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”
The FDA noted that it has received adverse event reports after patients used compounded semaglutide, and encouraged the public to report any additional adverse events through their MedWatch Adverse Event Reporting Program.
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