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FDA Warns About Certain Compounded Semaglutide Products

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The FDA has received adverse event reports after patients have used compounded semaglutide that contains salt formulations, which are different active ingredients than that used in the agency-approved drugs for diabetes and weight loss.

The FDA is warning patients that some compounded semaglutide products may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. The salt forms are different active ingredients than that used in the FDA-approved drugs, which contain the base form of semaglutide. FDA has received adverse event reports after patients have used compounded semaglutide.

The regulatory agency is updating the guidance because some patients are buying the compounded semaglutide salts from online pharmacies. “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. Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA.

The Alliance for Pharmacy Compounding also advised patients not to purchase any substance purported to be semaglutide from an online entity. The APC said none of its members would be using the salt form of semaglutide. “It is APC’s current position that compounding with semaglutide sodium technically is not eligible to be used in a compounded medication,” the organization said.

Novo Nordisk’s Wegovy and Ozempic are two semaglutide medications that have been in short supply for 14 months. As of May 2023, Ozempic and Wegovy are still listed on FDA’s Drug Shortages list.

In addition to treating type 2 diabetes, Ozempic is also approved to reduce the risk of heart attack, stroke, or death in adults with type 2 diabetes mellitus and known heart disease. Wegovy is approved to help adults and children aged 12 years and older with obesity or some adults with excess weight.

While Novo Nordisk is “actively producing and shipping all dose strengths of Wegovy…prescribing trends continue to increase at a substantial rate and indicate that demand for Wegovy in the United States will exceed our current supply capacity,” a Novo Nordisk spokesperson told Formulary Watch. “We will only be able to supply limited quantities of 0.25 mg, 0.5 mg, and 1 mg dose strengths to wholesalers for distribution to retail pharmacies, which will not meet anticipated patient demand. We anticipate that many patients will have difficulty filling Wegovy prescriptions at these doses through September 2023.”

On the other hand, Novo Nordisk does not currently anticipate supply interruptions of the 1.7 mg and 2.4 mg dose strengths of Wegovy and said that all doses of Ozempic are now available to retail pharmacies nationwide. “However, pharmacies may experience normal delays given the time required to order the product from their local distribution center, and geographical variabilities,” the spokesperson said..

If patients choose to use an online pharmacy, FDA suggested its BeSafeRx campaign, that provides resources and tools to assist in “making safer, more informed decisions when purchasing prescription medicine online.”



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