April 26, 2025
FDA Cracks Down on Off-Brand Ozempic and Wegovy: What You Need to Know If You’re Using Them
The U.S. Food and Drug Administration (FDA) has issued a warning against the use of off-brand or compounded versions of the popular weight-loss drugs Ozempic and Wegovy. These medications, which contain the active ingredient semaglutide, are approved for the treatment of type 2 diabetes and obesity, respectively. However, due to high demand and intermittent shortages, some patients have turned to compounded versions of semaglutide, which the FDA cautions may not be safe or effective.
Understanding the FDA's Warning
Compounded drugs are custom-made medications prepared by pharmacies to meet the specific needs of individual patients. While compounding can be beneficial in certain circumstances, compounded versions of semaglutide have raised concerns. The FDA reports that some compounded semaglutide products may contain salt forms like semaglutide sodium and semaglutide acetate, which differ from the FDA-approved semaglutide used in Ozempic and Wegovy. These alternative forms have not been proven safe or effective for human use.
Additionally, the FDA has received reports of adverse events associated with the use of compounded semaglutide, though specific details have not been disclosed. The agency emphasizes that compounded drugs are not FDA-approved and do not undergo the rigorous evaluation for safety, effectiveness, or quality that approved medications do.
Risks Associated with Off-Brand Versions
The use of off-brand or compounded semaglutide has been linked to serious health risks. In some cases, patients have experienced severe side effects, including gastrointestinal issues and hypoglycemia. There have also been reports of hospitalizations and even deaths related to the use of these unapproved versions.
One notable case involved a woman who obtained a weight-loss injection from an online source and suffered severe side effects, including vomiting blood, after taking a dose that was five times higher than recommended. This incident underscores the dangers of using unverified and unregulated products.
Guidance for Current Users
If you are currently using Ozempic or Wegovy, or considering starting treatment, the FDA recommends the following:
Obtain Medications Through Proper Channels: Only use semaglutide-containing drugs prescribed by a licensed healthcare provider and dispensed by a state-licensed pharmacy or an FDA-registered facility.
Avoid Online Purchases from Unverified Sources: Be cautious of online vendors selling semaglutide, especially if the product is labeled as "research use only" or lacks clear regulatory approval.
Consult Your Healthcare Provider: If you have been using a compounded version of semaglutide, discuss this with your doctor. They can help assess any potential risks and determine the best course of action.
Report Adverse Effects: If you experience any side effects or adverse reactions, report them to the FDA's MedWatch Adverse Event Reporting program.?
Explore Alternative Treatments: In light of the shortages, discuss other FDA-approved treatment options for diabetes or weight loss with your healthcare provider. There may be suitable alternatives that are safe and effective.
The FDA's warning serves as a critical reminder of the importance of using medications that have been thoroughly evaluated for safety and efficacy. While the demand for weight-loss treatments like Ozempic and Wegovy is high, turning to unapproved, compounded versions poses significant health risks. Always consult with a healthcare professional before starting or continuing any medication regimen, and ensure that your prescriptions are filled through reputable, licensed pharmacies.