This content originally appeared on On a regular basis 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 lively ingredient in Wegovy and Ozempic.

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

However the FDA has raised concerns that patients may experience unanticipated unintended effects with compounded semaglutide, which could also be made with salt-based types of semaglutide which might be different from the lively ingredient in Wegovy and Ozempic.

“Patients needs to be aware that some products sold as ‘semaglutide’ may not contain the identical lively ingredient as FDA-approved semaglutide products and stands out as the salt formulations,” the FDA said in a statement. “Products containing these salts, resembling semaglutide sodium and semaglutide acetate, haven’t been shown to be secure and effective.”

Unknown Hostile Events Reported From Compounded Semaglutide

The FDA said it has received hostile event reports after patients used compounded semaglutide. The FDA didn’t reply to requests for comment on how many individuals experienced unintended effects or what unintended effects patients had.

High levels of sodium within the body can result in hypertension, a risk factor for heart attacks and strokes. The FDA didn’t reply to requests for comment on whether any patients experienced hypertension or other cardiovascular unintended effects after taking compounded semaglutide.

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

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

“Our clinic doesn’t prescribe compounded semaglutide because the standard control process is just not as rigorous for compounding pharmacies because it is for normal pharmaceutical manufacturing,” Dr. Gilden says.

As a substitute, he says, individuals who struggle to fill semaglutide prescriptions should consider alternative FDA-medications for weight reduction or diabetes management.

What Are GLP-1 Agonists?

Semaglutide is in a family of medicines generally known as GLP-1 agonists, which may aid weight reduction by mimicking the motion of a hormone that curbs hunger and aids diabetes management by improving how the body uses a hormone needed to manage blood sugar levels. Liraglutide (Victoza), one other drug in the identical family of medicines, can also be FDA-approved to assist weight reduction and manage type 2 diabetes. Tirzepatide (Mounjaro), one other GLP-1 agonist, is simply approved to treat type 2 diabetes for now, but its manufacturer plans to seek FDA approval to be used as a weight reduction drug before the tip of the 12 months.

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 discover a pharmacy that has the drugs in stock,” Gilden says. When this doesn’t work, compounded semaglutide still isn’t the reply, he adds. “There are alternative medicines for diabetes and for weight reduction.”

If patients do shop around for semaglutide, they need to 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 which have not undergone appropriate evaluation or approval, or don’t meet quality standards,” the FDA said in its statement. “Should you select to make use of a web-based pharmacy, the FDA’s BeSafeRx campaign resources and tools can assist in making safer, more informed decisions when purchasing prescription medicine online.”