FDA Warns of Safety Issues With Compounded Forms of Semaglutide

This content originally appeared on Everyday Health. Republished with permission.

By Lisa Rapaport

The U.S. Food and Drug Administration (FDA) is warning against turning to compounding pharmacies for generic versions of semaglutide, the active ingredient in Wegovy and Ozempic.

Compounded drugs may mix, combine, or alter ingredients to make medications that are tailored to the needs of individual patients. Medicines may be compounded when there are shortages of FDA-approved drugs — which is the case with Wegovy and Ozempic — the FDA said.

But the FDA has raised concerns that patients may experience unanticipated side effects with compounded semaglutide, which may be made with salt-based forms of semaglutide that are different from the active ingredient in Wegovy and Ozempic.

“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,” the FDA said in a statement. “Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”

Unknown Adverse Events Reported From Compounded Semaglutide

The FDA said it has received adverse event reports after patients used compounded semaglutide. The FDA didn’t respond to requests for comment on how many people experienced side effects or what side effects patients had.

High levels of sodium in the body can lead to high blood pressure, a risk factor for heart attacks and strokes. The FDA didn’t respond to requests for comment on whether any patients experienced high blood pressure or other cardiovascular side effects after taking compounded semaglutide.

Several medical experts also declined to comment on whether salt-based forms of semaglutide might raise patients’ blood pressure, noting that there’s no research on these versions of the drug that would prove what specific effects they have in the body.

Compounded versions of salt-based semaglutide haven’t been studied in rigorous clinical trials to determine whether they’re safe or effective, says Adam Gilden, MD, an associate professor at the University of Colorado School of Medicine in Aurora who treats people with obesity and diabetes.

“Our clinic does not prescribe compounded semaglutide because the quality control process is not as rigorous for compounding pharmacies as it is for regular pharmaceutical manufacturing,” Dr. Gilden says.

Instead, he says, people who struggle to fill semaglutide prescriptions should consider alternative FDA-medications for weight loss or diabetes management.

What Are GLP-1 Agonists?

Semaglutide is in a family of medicines known as GLP-1 agonists, which can aid weight loss by mimicking the action of a hormone that curbs hunger and aids diabetes management by improving how the body uses a hormone needed to regulate blood sugar levels. Liraglutide (Victoza), another drug in the same family of medicines, is also FDA-approved to aid weight loss and manage type 2 diabetes. Tirzepatide (Mounjaro), another GLP-1 agonist, is only approved to treat type 2 diabetes for now, but its manufacturer plans to seek FDA approval for use as a weight loss drug before the end of the year.

Where Can I Safely Fill My Ozempic or Wegovy Prescription?

When shortages make it hard to get semaglutide, “we recommend that patients call around until they find a pharmacy that has the medicine in stock,” Gilden says. When this doesn’t work, compounded semaglutide still isn’t the answer, he adds. “There are alternative medicines for diabetes and for weight loss.”

If patients do shop around for semaglutide, they should only get it with a prescription and buy it from a licensed pharmacy, the FDA said.

“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,” the FDA said in its statement. “If you choose to use an online pharmacy, the FDA’s BeSafeRx campaign resources and tools can assist in making safer, more informed decisions when purchasing prescription medicine online.”

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