Dr. Jen Caudle discusses the use of off-brand versions or compounded drugs of Ozempic, Wegovy, and Semaglutide. These medications are used for weight loss and diabetes but are currently facing shortages, leading people to seek alternatives. Dr. Caudle explains that there are three FDA-approved Semaglutide products, including Ozempic, Wagovy, and Rybelsus, and that they have undergone rigorous testing for safety and effectiveness. However, due to the shortage and they are being listed on FDA's drug shortages list, compounding pharmacies may be able to make a compounded version of that drug if they meet certain requirements.
What is compounding? It's when a pharmacy actually sort of combines or mixes or changes ingredients to create a medication tailored to the needs of an individual patient. Usually, it involves combining two or more drugs. But compounded drugs are not FDA approved, and the agency does not verify the safety or effectiveness of compounded drugs. So when there's compounded Semaglutide, that means they're custom made. That means that pharmacies will use a recipe that's likely different from Ozempic or Wegovy, and the compounded Semaglutide may have different or extra ingredients. And the product doesn't go through the same rigorous testing and approval process that Ozempic and Wegovy go through. In other words, the FDA does not evaluate their safety and effectiveness. But just like Ozempic and Wegovy, compounded Semaglutide injections do require a prescription.
The FDA has issued a warning regarding compounded Semaglutide, citing adverse event reports from patients, although specific side effects are not detailed. The warning notes that compounders might be using Semaglutide salt forms, such as Semaglutide sodium and Semaglutide acetate, which differ from the approved drugs containing the base form of Semaglutide. And the FDA is unaware of any basis for compounding with these salt forms that would meet the requirements. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
So the key points to remember from the FDA warning are:
1). Some products sold as Semaglutide may be the salt formulation (Semaglutide sodium or Semaglutide acetate), and these do NOT actually have the same active ingredient as the FDA-approved Semaglutide products! These salt formulations have not been shown to be safe and effective.
2). You should only obtain drugs containing Semaglutide with a prescription from a licensed healthcare provider and only obtain medications from state-licensed pharmacies or outsourcing facilities registered with FDA .
3). Purchasing medicine online from unregulated, unlicensed sources can expose you to potentially unsafe products that have not undergone appropriate evaluation or approval or do not meet quality standards. If you want to use an online pharmacy, go to the FDA's BeSafeRX campaign to look at their resources and tools to be able to make informed decisions.
Additional Resources:
State-licensed online pharmacy list:https://www.fda.gov/drugs/besaferx-your-source-online-pharmacy-information/locate-state-licensed-online-pharmacy
Outsourcing facilities registered with FDA:https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities
FDA's BeSafeRx campaign page:https://www.fda.gov/drugs/quick-tips-buying-medicines-over-internet/besaferx-your-source-online-pharmacy-information
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