FDA warns of issues of safety with compound types of semaglutide


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This content originally appeared on everyday health. Republished with permission.

By Lisa Rapaport

The U.S. Food and Drug Administration (FDA) warns against going to pharmacies that manufacture drugs for generic versions of semaglutide, the active ingredient in ways And Ozempic.

Compound medicines can mix, combine, or alter ingredients to create medicines tailored to the needs of individual patients. Medicaments can optionally be compound bottlenecks of FDA-approved drugs – that’s the Case with Wegovy and Ozempic – said the FDA.

However, the FDA has raised concerns that patients could experience unexpected side effects with compound semaglutide, which may be made from salt-based forms of semaglutide that differ 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 salt formulations,” the FDA said in a statement opinion. “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 compound semaglutide

The FDA said it had received reports of adverse events after patients used compound semaglutide. The FDA did not respond to requests for comment on how many people had side effects or what side effects patients had.

High levels of sodium in the body can cause this high blood pressure, a risk factor for heart attacks and strokes. The FDA did not respond to requests for comment on whether patients experienced high blood pressure or other cardiovascular side effects after taking compound semaglutide.

Several medical experts also declined to comment on whether salt-based forms of semaglutide could increase patients’ blood pressure, pointing out that there was no research on these versions of the drug to prove what specific effects they had have the body.

Compound salt-based versions of semaglutide have not been evaluated in rigorous clinical trials to determine whether they are safe or effective, it said Adam Gilden, MDan associate professor at the University of Colorado School of Medicine at Aurora who treats people with obesity and diabetes.

“Our clinic does not prescribe compound semaglutide because the quality control process in drug pharmacies is not as strict as in regular drug manufacturing,” says Dr. guilds.

Instead, he says, people who have trouble following semaglutide prescriptions should consider alternative FDA drugs for weight loss or diabetes management.

What are GLP-1 agonists?

Semaglutide belongs to a family of medicines known as GLP-1 agonists. They may aid in weight loss by mimicking the action of a hormone that curbs hunger and aid in the management of diabetes by improving use of a hormone the body needs to regulate blood sugar levels. Liraglutide (Victoza), another drug in the same drug family, is also FDA-approved to aid in weight loss and to treat type 2 diabetes. tirzepatid (Mounjaro), another GLP-1 agonist, is only approved for treat type 2 diabetes for now, but the manufacturer plans to do so seek FDA approval for use as a weight loss drug before the end of the year.

Where can I safely redeem my Ozempic or Wegovy prescription?

When it’s difficult to get semaglutide due to shortages, “we encourage patients to keep calling until they find a pharmacy that stocks the drug,” says Gilden. If that doesn’t work, compound semaglutide still isn’t the answer, he adds. “There are alternatives Medicines for diabetes and for weight loss.”

If patients are looking for semaglutide, they should only obtain it with a prescription and buy it from an approved pharmacy, the FDA said.

“Purchasing drugs online from unregulated, unlicensed sources can expose patients to potentially unsafe products that have not undergone proper evaluation or approval, or that do not meet quality standards,” the FDA said in its statement. “If you decide to use an online pharmacy, the FDA has jurisdiction BeSafeRx Campaign resources and tools can help make safer, more informed decisions when buying prescription drugs online.”

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