Did you know that Semaglutide, a medication known to regulate insulin, not only treats type 2 diabetes but also helps with weight loss? With three options endorsed by the Food and Drug Administration (FDA) – Ozempic and Wegovy as injectables, and Rybelsus as a tablet – they offer substantial benefits for both diabetes management and achieving weight loss goals.
Now, let’s see how Semaglutide works and check out its different versions. We’ll also talk about any important FDA warnings, giving you the important details that you need to know.
Mechanism of Action
Semaglutide replicates the natural release of the GLP-1 hormone in the gastrointestinal tract triggered by food consumption. The primary role of GLP-1 includes stimulating insulin production, reducing blood glucose levels, and influencing parts of the brain that control appetite and induce a sense of fullness.
FDA-Approved Semaglutide Products
Semaglutide is available in three major products for treating diabetes and weight-related issues:
Ozempic: It is approved for diminishing blood glucose levels in people with type 2 diabetes. It is additionally authorized to alleviate the risk of heart attack and stroke.
Wegovy: It is approved to assist adults and certain adolescents in weight loss, particularly those with obesity or excess weight and weight-related medical problems. It is meant to be used in conjunction with a controlled diet and regular exercise.
Rybelsus: It is approved for lowering blood sugar levels in type 2 diabetes patients, along with dietary and exercise measures.
Compounding of Semaglutide
In situations where a particular drug like Semaglutide faces a shortage, pharmacies are authorized to create custom versions. However, it is essential to note that compounded drugs, which involve altering or combining existing medications, including those containing Semaglutide, bypass the rigorous oversight of the FDA.
Concerns with Compounded Semaglutide
The Food and Drug Administration (FDA) expressed increased concerns about compounded Semaglutide, particularly those incorporating different salt forms than the base Semaglutide used in approved drugs. These concerns led the FDA to strongly advise against using such formulations.
FDA Warnings and Actions
In response to emerging concerns, the FDA has consistently issued warnings against the utilization of compounded Semaglutide medications. The agency’s apprehensions revolve around the incorporation of salt forms in compounded products, contributing to chemical disparities from the FDA-approved Semaglutide.
Patient and Professional Guidance
Patients are urged to obtain Semaglutide products only with a prescription from licensed healthcare providers and state-licensed pharmacies or FDA-registered outsourcing facilities. Healthcare professionals are instructed to exercise caution when considering compounded Semaglutide and be aware of the potential use of salt forms by compounders.
