Compounded Semaglutide Variants For Diabetes And Weight Loss Raise Safety Concerns

Obesity is a primary medical condition that requires innovative strategies and acknowledged global consensus in treating illnesses that cause morbidity. 

The US Food and Drug Administration recently approved the glucagon-like peptide-1 receptor agonist semaglutide for managing chronic weight. Adult obesity is treated with a once-weekly 2.4-mg dosage of subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist. 

According to the study published in The New England Journal of Medicine, “With reductions of almost 15% of baseline weight at 68 weeks, liraglutide has produced the biggest weight loss of any obesity medicine to date, along with improvements in cardiovascular risk factors and physical performance. With this medication’s approval, patients now have more alternatives for managing their weight”. 

But the medicine semaglutide, authorized for treating diabetes and excess weight, was compounded, but the US Food and Drug Administration warned about it. 

After patients took compounded semaglutide, reports of adverse events were submitted to the FDA. If patients can be treated with an approved prescription, they shouldn’t use compounded medication. Patients and healthcare professionals should be aware that the FDA does not assess the quality, effectiveness, or safety of compounded versions of these medications. 

The FDA defines compounding as “the process of combining, mixing, or altering ingredients to create a medication customized to the needs of a specific patient.” Combining two or more medications is referred to as “compounding.” The FDA has approved semaglutide, a GLP-1 agonist, under Ozempic and Rybelsus, to treat type 2 diabetes and Wegovy to treat obesity and overweight people. 

Since last year, Ozempic and Wegovy have been on the FDA’s list of unmet medical needs. The FDA states that compounders “may be able to prepare a compounded version of that drug when a drug is in shortage if they meet certain Federal Food, Drug, and Cosmetic (FD&C) Act requirements.” Still, the organization needs to evaluate these compounded versions for quality, safety, or effectiveness. 

According to the FDA, complaints of adverse side effects in users of compounded semaglutide have been reported, and patients “should not use a compounded drug if an approved drug is available.” According to the FDA, patients, and healthcare professionals should be aware of these variations in compounded drugs. 

Patients should only buy semaglutide-containing medications with a prescription from a doctor or other qualified healthcare professional, and they should only buy their medications from state-licensed pharmacies or FDA-registered outsourcing facilities. 

Healthcare providers should be aware that compounders may use salt versions of semaglutide when considering working with them to obtain semaglutide products. According to FDA, there isn’t any legal justification for mixing medicine with semaglutide salts. 

Last week, The Alliance for Pharmacy Compounding released a statement on semaglutide in which it cautioned customers against purchasing anything marketed as semaglutide online without a prescription or without being able to confirm that the seller is an authorized US pharmacy. 

The association advises anyone who has been administered compounded semaglutide and wishes to confirm the components to seek the chemist for a certificate of analysis and test results from independent laboratories.