Semaglutide is a medication used for managing type 2 diabetes and supporting weight management. It is available in FDA-approved formulations and versions prepared by compounding pharmacies. This article explores how semaglutide functions, the characteristics of compounded versions, and its effectiveness and safety.
Understanding Semaglutide’s Mechanism
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the action of GLP-1, a natural hormone produced in the gut when food is consumed. The drug works by binding to GLP-1 receptors, initiating effects that regulate metabolism and appetite.
It slows gastric emptying, keeping food in the stomach longer, which contributes to fullness and reduced food intake. Semaglutide stimulates the pancreas to release more insulin when blood sugar is high, lowering blood glucose. It also suppresses glucagon release, a hormone that increases liver glucose production. Semaglutide acts on appetite centers in the brain, reducing hunger and cravings.
The Nature of Compounded Semaglutide
Compounded semaglutide is custom-made by licensed compounding pharmacies, often when FDA-approved drugs are unavailable or patients have allergies to commercial product ingredients. During shortages of FDA-approved semaglutide, compounding pharmacies have increased production of these versions.
FDA-approved medications undergo rigorous testing for safety, efficacy, and quality. Compounded drugs do not go through this same pre-market approval process; the FDA does not verify their safety, effectiveness, or quality. Some compounded products may contain different forms of the active ingredient, such as semaglutide sodium or acetate salts, rather than the base semaglutide in FDA-approved versions. The FDA has stated it lacks information on whether these salt forms have the same properties as the approved drug’s active ingredient.
Effectiveness for Weight Management and Blood Sugar Control
Clinical trials have demonstrated the substantial effectiveness of FDA-approved semaglutide in both weight management and blood sugar control. For individuals with obesity or overweight, studies show that participants achieved an average weight loss of approximately 14.9% to 17.4% of their initial body weight over 68 weeks with semaglutide 2.4 mg. In some studies, up to 30% of adults taking semaglutide lost 20% or more of their body weight. This level of weight reduction can lead to clinically relevant improvements in health.
For people with type 2 diabetes, semaglutide has consistently shown significant reductions in glycated hemoglobin (HbA1c) levels, a key indicator of long-term blood sugar control. Reductions in HbA1c typically range from 0.6% to 1.6% points across various trials. These positive outcomes are supported by extensive data from large, well-controlled clinical trials involving FDA-approved semaglutide products. Compounded versions do not possess the same level of clinical trial evidence for their specific formulations, purity, or efficacy. While they may contain the same active ingredient, variations in product quality, stability, and absorption in compounded preparations could affect their overall effectiveness.
Potential Side Effects and Safety Considerations
Semaglutide, regardless of its form, can cause various side effects. Common side effects often involve the gastrointestinal system and include nausea, vomiting, diarrhea, constipation, and abdominal pain. These effects are usually mild to moderate and often improve as the body adjusts to the medication. More serious, though less common, side effects can include pancreatitis (inflammation of the pancreas), gallbladder problems such as gallstones, and acute kidney injury. There is also a boxed warning regarding thyroid C-cell tumors based on animal studies, although this risk has not been confirmed in humans.
Compounded semaglutide carries additional safety concerns primarily due to the lack of stringent FDA oversight. Risks include the potential for impurities or contaminants in the preparation, which have been found in some tested compounded products. There is also a risk of inconsistent dosage or potency, meaning the medication might contain too much or too little active ingredient, potentially leading to adverse events or reduced efficacy. Furthermore, compounded products may lack the rigorous quality control and sterility testing applied to FDA-approved drugs, increasing the risk of contamination. Some reports indicate adverse events, including hospitalizations, linked to compounded semaglutide, highlighting the importance of obtaining medication from verified sources.