FDA Warns Consumers Not to Use Certain Versions of Popular Drug

'Compounded' versions of Ozempic and Wegovy under federal scrutiny

FDA Warns Consumers Not to Use Certain Versions of Popular Drug
Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. (Andrew Kelly/Reuters)
Jack Phillips

The U.S. Food and Drug Administration (FDA) warned consumers not to use off-brand versions of weight-loss drugs Ozempic, Rybelsus, and Wegovy because they may not have the same ingredients.

Those off-brand versions of the drugs are possibly unsafe or ineffective, the federal regulator said in a notice this week. Officials said they received reports of problems linked to "compounded" versions of semaglutide, the drug's active ingredient.

"Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient," the agency said. "Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs."

Compounding is sometimes allowed in pharmacies during drug shortages, according to the FDA. However, those drugs have not met certain standards under the U.S. Federal Food Drug and Cosmetic Act, said the agency.

Compounded semaglutide can contain a version of the ingredient that is not approved for human use, said the FDA. It also warned that reports have indicated some versions of compounded semaglutide contain salt, which changes the drug.

“The agency is not aware of any basis for compounding using the salt forms that would meet the [Federal Food Drug and Cosmetic Act] requirements for types of active ingredients that can be compounded,” the FDA said.

"Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations," said the notice, adding that drugs "containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective."

Boxes of the diabetes drug Ozempic rest on a counter at a pharmacy in Los Angeles, Calif., on April 17, 2023. (Mario Tama/Getty Images)
Boxes of the diabetes drug Ozempic rest on a counter at a pharmacy in Los Angeles, Calif., on April 17, 2023. (Mario Tama/Getty Images)

Sales of semaglutide products—particularly Ozempic—have soared in the past few years after the drug was shown to spur fast and significant weight loss. The drugs manufactured by Novo Nordisk include the brands Ozempic and Rybelsus, which are approved to treat diabetes, and Wegovy, which is approved by the FDA to treat obesity.

Several weeks ago, Novo Nordisk promised to boost its supply of Wegovy. However, in the company’s first-quarter earnings report, the firm said that it would “temporarily” reduce U.S. supply.

Demand for the medications has outstripped supply. As of May, Ozempic and Wegovy remain on the FDA’s list of drug shortages. When drugs are in short supply, compounding pharmacies are permitted to produce versions of those medications.

Consumers should only use drugs containing semaglutide with a prescription from a licensed health care provider and obtained from a state-licensed pharmacy or other facilities registered with the FDA, the agency said.

The FDA said it has received "adverse event reports" after patients received compounded versions of semaglutide. It then warned that "patients should not use a compounded drug if an approved drug is available to treat a patients" and that "patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality."

Furthermore, "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," said the notice.

Officials in states like Louisiana, Mississippi, North Carolina, and West Virginia have threatened to take action against pharmacies that make compounded, unauthorized versions of Ozempic and Wegovy, according to reports.
"The Board is charged with protecting the public," said the West Virginia Board of Pharmacy, a body that oversees pharmacies in the state, said in an April 21 statement. "Therefore, compounding semaglutide drug products in a way that fails to conform with governing law may lead to enforcement action."

Other Trends

The warning comes as some social media users have reported seeing weight-loss results from the supplement berberine, which is found in a range of plants, including traditional Chinese medicine and Aryuvedic herbs. The chemical is found in European barberry, goldenseal, goldthread, Oregon grape, phellodendron, and tree turmeric, but supplements are sold via Amazon, Walmart, and other online retailers.
Some health experts said that the supplement is not without side effects, and people should take caution before using it. What's more, it may have negative interactions with other drugs, including certain blood pressure drugs, cough suppressants like dextromethorphan, cyclosporine, and more, according to a federal drug website, MedlinePlus.
In recent days, there have been a handful of corporate media reports suggesting that berberine may not be safe. Those reports included quotes from doctors and health experts, including one who said that "it is an herb" and "herbs can counteract with other medications, supplements and cause harm in quite a few populations."

"Berberine is possibly safe for most adults. It's been used safely in doses up to 1.5 grams daily for 6 months. Common side effects include diarrhea, constipation, gas, and upset stomach," says the MedlinePlus website.

The Associated Press contributed to this report.
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