The FDA is cracking down on cheaper Ozempic copycats — while they may cause weight loss, they can carry serious risks
Regulators warn against knockoff versions of weight-loss drugs. These unapproved, and often cheaper, medications could contain harmful substances
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- The FDA warns that the weight loss medication market is full of potentially risky copycat drugs.
- Compounded semaglutide may contain substances that haven't been tested for safety or effectiveness.
- It's often prescribed online without proper evaluation or follow-up from a doctor.
The US Food and Drug Administration (FDA) is cautioning against the use of some versions of a popular weight-loss medication often sold online, noting that patients have been reporting adverse effects.
The warning, posted on the FDA website May 30, states that some pharmacies have been using an unapproved version of semaglutide, the active ingredient in brand name medications Ozempic and Wegovy, used for diabetes treatment and weight management.
The high demand for the medications has prompted shortages of the FDA-approved products, made by pharmaceutical company Novo Nordisk, giving rise to a market for a generic version known as compounded semaglutide.
Compounded medications can be safe and effective, and typically involve a pharmacist preparing the active ingredient for a specific patient's unique needs, such as customizing the dose, offering it in liquid instead of solid form, or removing allergens.
However, these formulations usually involve drugs that have an approved generic version. The semaglutide molecule is patented by Novo Nordisk, and the manufacturer says it doesn't sell it to compounding pharmacies.
As a result, it's unclear where makers of compounded semaglutide are sourcing the drug. According to the FDA, some pharmacies have been reported for using different versions of the substance called semaglutide sodium or semaglutide acetate, which are not FDA-approved and haven't been tested for safety or effectiveness.
Since semaglutide is administered via once-weekly injections, it needs to be prepared in a sterile environment, which could also be a concern for patients buying from unapproved or unregistered sources.
Compounded semaglutide requires a specific prescription to obtain — however, online providers often offer access to the drug without the appropriate medical oversight or follow-up, doctors and pharmacy experts previously told Insider.
According to the FDA statement, doing so can be risky.
"Purchasing medicine online from unregulated, unlicensed sources can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval, or do not meet quality standards," the statement says.