FDA Warns Consumers Not To Use Certain Versions Of Popular Drug
Authored by Jack Phillips via The Epoch Times (emphasis ours),
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.”
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.
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