Ozempic and Wegovy: FDA warns of increase in off-brand versions

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The FDA has issued a warning against compound drugs similar to Ozempic and Wegovy that haven’t been tested for safety or efficacy. Terry Vine/Getty Images
  • The FDA has issued a warning on GLP-1 drugs similar to Ozempic and Wegovy.
  • These drugs differ from FDA-approved Ozempic and Wegovy because they are made by online pharmacies and other uncertified sources.
  • These compound drugs are made by mixing or altering drugs to create a semaglutide-like drug.
  • The health risks of the compound semaglutide are not yet known, but off-label versions of the drug may contain contaminants.
  • The FDA cannot verify the safety or efficacy of compound semaglutide drugs, especially those made with salt, that have not undergone rigorous testing.

The Food and Drug Administration (FDA) has issued a warning against modified glucagon-like peptide-1 (GLP-1) drugs, such as semaglutide, that are being sold.

The United States has experienced a shortage in both Ozempic, used to treat type 2 diabetes, and Wegovy, used to treat obesity, since early May 2023.

As a result, online pharmacies and uncertified sources sell GLP-1 drugs made with different ingredients than those used in approved drugs.

These drugs, called compound drugs due to mixing or altering ingredients to create a drug, are marketed as semaglutide.

Compound drugs aren’t approved by the FDA, and the agency doesn’t test compound drugs for safety or efficacy, the FDA said in his warning.

The FDA issued the warning after the agency received reports of people taking the compound semaglutide.

The compounded drugs may contain unwanted contaminants or have a different potency than FDA-approved drugs, Dr. Kelly Johnson-Arbor, a medical toxicologist and co-medical director of the National Capital Poison Center, told Healthline.

There have been incidents of people becoming very ill and even dying from other types of compound drugs, Johnson-Arbor said.

In some cases, the compound semaglutide drugs consisted of saline forms of semaglutide, including semaglutide sodium and semaglutide acetate, which are different from the FDA-approved versions of semaglutide sold under the brand names Ozempic and Wegovy.

According to the FDA, these salt versions have not been shown to be safe or effective.

It is also not clear what the health risks are.

Essentially, you’d be using an uncontrolled substance, possibly illegally imported into the United States, with no control over what’s in it, Dr. Dan Azagury, an associate professor of surgery at Stanford Healthcare, told Healthline.

The Alliance for Compounded Pharmacy released a statement last week saying the compound semaglutide is technically ineligible to be sold by compounding pharmacies.

Some compounding drugs may be legally prescribed by a licensed health care practitioner and sold by compounding pharmacies as they must meet stringent compounding standards.

For example, people with an allergy to a certain dye can get the drug without it, says Azagury.

But in this situation, the current semaglutide molecule is probably only produced by Novo Nordisk. If they don’t have enough, no one does, Azagury said.

David Lebo, PhD, a professor of pharmaceutical sciences at Temple University’s School of Pharmacy, explained to Healthline that compounding should never be used as a substitute for a commercial product, such as Ozempic, unless there are specific reasons such as adjustments to the dose, route of administration or to make the drug available to special populations.

To avoid buying a compound version of semaglutide, you should only get your prescription through a licensed healthcare professional and pick up your medications from a state-licensed pharmacy or facility registered with the FDA.

The APC has warned consumers to avoid unreliable online retailers.

If your doctor hasn’t written you a prescription for the compound semaglutide and mailed it to a legitimate, identifiable pharmacy, be wary of the seller of that substance, says the APC.

If you are buying your medications online, make sure that the retailer is licensed and regulated and that the medications are made by the drug manufacturer Novo Nordisk.

For tips on evaluating the legitimacy of your online retailer, visit the FDA website BeSafeRx.

Illegitimate versions of semaglutide tend to be cheaper.

When searching for semaglutide online, look for clues such as not for human use or laboratory use only to identify formulations of the drug that are intended for use only as research chemicals and are not approved by the FDA for use in the man, Johnson-Arbor said.

If you think you have taken or purchased compound semaglutide, report the incident to the FDA MedWatch Adverse Event Reporting.

A certified healthcare provider can help you get the drug in a supervised process with the right support, Azagury said.

If you can’t access semaglutide due to a shortage, there are several other drugs in this class, Lebo said.

Patients should have a conversation with their doctor or pharmacist about some of the options, Lebo noted.

The FDA has issued a warning against modified GLP-1 drugs, such as semaglutide, that are being sold.

There was a shortage in both Ozempic and Wegovy since May 2023, and some uncertified resellers are selling a modified version of the drug made with saline forms of semaglutide.

The salt versions haven’t been tested, so it’s unclear how safe and effective they are, and what the health risks are.

Health experts say you should not take fake or compounded semaglutide under any circumstances.

You are working on losing weight to improve your health so as not to endanger it by using these drugs, Azagury said.

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