DEMYSTIFYING SEMAGLUTIDE SALTS: UNDERSTANDING THEIR USES AND SAFETY CONSIDERATIONS

In recent times, semaglutide salts have captured considerable attention within the medical community. Questions abound regarding their potential as alternatives to brand-name medications like Ozempic and Wegovy, particularly during periods of drug shortages. To shed light on this topic, we sat down with Ammy Man, a senior pharmacist, to delve into the realm of semaglutide salts, their applications, and the safety considerations associated with their use.

UNDERSTANDING SEMAGLUTIDE SALT AND ITS APPLICATIONS:

Semaglutide, the active component found in renowned medications such as Wegovy and Ozempic, belongs to a class of drugs known as peptide-based GLP-1 receptor agonists. These medications emulate the actions of a naturally occurring hormone called GLP-1, exerting effects on appetite reduction and digestion regulation by binding to specific receptors in the body.

While semaglutide in its base form has undergone extensive clinical evaluation, the salt formulations, which exhibit slight variations, have not been subjected to large-scale clinical studies. Salt forms of medications are commonly employed for various therapeutic purposes, altering factors such as drug potency and duration of action. However, it’s important to note that the effects of semaglutide salts have not been rigorously assessed.

NAVIGATING THE DRUG SHORTAGE DILEMMA:

Despite being under exclusive patent rights, certain dosages of brand-name medications like Ozempic and Wegovy have found themselves on the FDA’s drug shortage list. This scarcity has prompted compounding pharmacies to explore alternatives, resulting in the production of compounded semaglutide. However, it’s imperative to highlight a crucial caveat—the FDA has cautioned against the use of semaglutide salts in compounding practices, citing deviations from regulatory requirements.

EVALUATING THE SAFETY OF SEMAGLUTIDE SALT:

The fundamental question looming over the discourse surrounding semaglutide salts pertains to their safety and efficacy. At present, there exists a dearth of empirical evidence to substantiate claims regarding their suitability as substitutes for established medications like Ozempic and Wegovy. The FDA has underscored the lack of sufficient data supporting the safety and efficacy of semaglutide salts, cautioning against their use in compounding practices.

THE FDA’S STANCE:

In response to the proliferation of semaglutide salts in compounding pharmacies, the FDA has issued explicit warnings, emphasizing the necessity for adherence to regulatory protocols governing drug compounding. Pharmacies utilizing semaglutide salts as active pharmaceutical ingredients are deemed non-compliant with FD&C requirements, thereby raising concerns regarding patient safety and regulatory compliance.

EMPHASIZING PATIENT SAFETY AND INFORMED DECISION-MAKING:

As discussions surrounding semaglutide salts continue to unfold, it’s imperative to prioritize patient safety and informed decision-making. While the allure of compounded medications may offer temporary respite amidst drug shortages, the absence of robust clinical data necessitates caution. Patients and healthcare providers alike must engage in open dialogue and exercise prudence when considering alternative treatment options.

DISCLAIMER:

If you have any medical questions or concerns, please talk to your healthcare provider. The articles on Health Guide are underpinned by peer-reviewed research and information drawn from medical societies and governmental agencies. However, they are not a substitute for professional medical advice, diagnosis, or treatment.

SOURCES:

FDA Drug Shortages. (n.d.). Retrieved from https://www.accessdata.fda.gov/scripts/drugshortages/
FDA. (2022). Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compounded-drug-products-are-essentially-copies-approved-drug-products-under-section-503b-federal
FDA. (2018). Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compounded-drug-products-are-essentially-copies-commercially-available-drug-product-under-section-503a
FDA. (2018). Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compounded-drug-products-are-essentially-copies-approved-drug-products-under-section-503b-federal
U.S. Pharmacopeia. (2022). USP Compounding Compendium. Retrieved from https://www.uspnf.com/usp-compounding-compendium