FDA Warns Against Using Compounded Semaglutide For Type 2 Diabetes, Weight Loss

The FDA issued a warning advising people to avoid using compounded versions of semaglutide, which is a glucagon-like peptide-1, as substitutes for popular weight loss and diabetes drugs. 

Unfortunately, the high demand for and surging popularity of new weight loss medications has resulted in a frustrating, long-lasting shortage for many. When a drug is low in supply, licensed medical professionals and pharmacists who meet the Federal Food, Drug, and Cosmetic Act criteria can prepare a compounded version. Semaglutide, the active ingredient in Ozempic, was placed on such shortage lists. 

That said, the FDA highlighted several concerns about compounded semaglutide, noting the potential for adverse reactions and other potential side effects. 

"FDA has received adverse event reports after patients used compounded semaglutide," according to the agency's most recent January press release. "Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and healthcare professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality."

As the FDA explains, semaglutide is a GLP-1 receptor agonist, a medication that mimics a natural hormone called GLP-1 released in the gastrointestinal tract when eating. GLP-1 induces the body to release insulin, which reduces blood sugar levels and signals a feeling of fullness.

One key concern about compounded semaglutide surrounds the practice of swapping out the pure version for salt forms. These are different active ingredients than the approved versions using the base form of semaglutide. The report underscored how such products are less safe and effective than Wegovy and Ozempic, which are FDA-approved semaglutide medications. 

Although legal, compounded medications are not approved like standard pharmaceutical ones and do not undergo clinical trials or other testing. The FDA thus advised against using compounded drugs if the approved version is available. However, during shortages, the FDA still urges patients to protect themselves by obtaining "prescription drugs only from state-licensed pharmacies that are located in the U.S., where FDA and state authorities can assure the quality of drug manufacturing, packaging, distribution and labeling."

In short, the FDA has yet to study these compounded combinations to verify their safety or efficacy, leaving the question of compounded semaglutide safety up in the air.