Wednesday, June 19, 2024

FDA Warning About Off-Brand Versions of Ozempic and Wegovy

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The FDA issued a warning against compounded drugs similar to Ozempic and Wegovy that haven’t been tested for safety or effectiveness.

  • 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 compounded drugs are made via mixing or altering medications to create a drug similar to semaglutide.
  • The health risks of compounded semaglutide are not yet known but off-label versions of the drug may contain contaminants.
  • The FDA cannot verify the safety or effectiveness of compounded semaglutide drugs, particularly those made with salt, which have not undergone rigorous testing.

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

The United States has been experiencing 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 are selling GLP-1 drugs made with different ingredients than what’s used in the approved drugs.

These drugs, called compounded drugs due to the mixing or altering of ingredients to create a medication, are being marketed as semaglutide.

“Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs,” the FDA stated in its warning.

What are off-brand versions of Ozempic and Wegovy?

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

“Compounded drugs may contain unwanted contaminants or have unequal potency to FDA-approved medications,” 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 getting severely ill and even dying from other types of compounded drugs, Johnson-Arbor said.

In some of the cases, the compounded semaglutide drugs were made of salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, which are different from the FDA-approved versions of semaglutide, which are 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’s also unclear what the health risks are.

“Essentially, you would be using an uncontrolled substance, likely illegally imported to the U.S., with no control of what’s in it,” Dr. Dan Azagury, an associate professor of surgery at Stanford Healthcare, told Healthline.

Compounded semaglutide does not meet rigorous standards

The Alliance for Pharmacy Compounded issued a statement last week stating that compounded semaglutide technically isn’t eligible to be sold by compounding pharmacies.

Certain compounded medications can be legally prescribed by a licensed healthcare provider and sold by compounding pharmacies as they must meet “rigorous compounding standards.”

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

“But in this situation, the actual semaglutide molecule is likely only manufactured by Novo Nordisk. If they don’t have enough, nobody 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, like Ozempic, unless there are specific reasons such as adjustments to dose, route of administration, or to make the drug available to special populations.

How to avoid off-brand Ozempic and Wegovy

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

The APC warned consumers to avoid unreliable online retailers.

“If your doctor didn’t write you a prescription for compounded semaglutide and send it to a legitimate, identifiable pharmacy, beware the seller of that substance,” the APC states.

If you are purchasing your medication online, ensure that the retailer is licensed and regulated and that the drugs are produced by the drug manufacturer Novo Nordisk.

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

Illegitimate versions of semaglutide tend to be cheaper.

“When searching for semaglutide online, look for clues like ‘not for human use’ or ‘for laboratory use only’ to identify formulations of the drug that are intended only for use as research chemicals and are not FDA-approved for use in humans,” Johnson-Arbor said.

If you think you took or purchased compounded semaglutide, report the incident to the FDA’s MedWatch Adverse Event Reporting.

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

If you cannot access semaglutide due to the shortage, there are plenty of 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 bottom line

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

There has been a shortage in both Ozempic and Wegovy since May 2023 and some uncertified retailers are selling a modified version of the drug that’s made with salt forms of semaglutide.

The salt versions have not undergone testing, 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 not to put it in jeopardy using these drugs,” Azagury said.

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