The FDA has released a statement concerning online purchasing of semaglutide. This medicine is used to treat type 2 diabetes and obesity or overweight individuals with health problems related to their weight.
Semaglutide works by mimicking a hormone released by the gut when we eat. It stimulates insulin production and, at high enough doses, has an effect on brain centers resulting in decreased appetite and feeling full.
There are 2 forms of semaglutide for treating type 2 diabetes: Ozempic (injectable) and Rybelsus (oral). In addition to helping control diabetes they reduce the risk of heart attack, stroke, or death in people with known heart disease.
There is only one FDA-approved version for weight loss, Wegovy (injection). It can be used in appropriate patients ages 12 and older. It should be used along with diet and exercise.
Because Ozempic and Wegovy are in short supply, some companies are making a form of semaglutide by a process called compounding. They are not tested and approved by the FDA.
It is not illegal to compound medications, but they are not subject to FDA oversight. The FDA has become aware of adverse events after using compounded semaglutide.
On their website, the FDA notes that “… in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate.” These forms of semaglutide are different from the FDA-approved one.
The salt forms “have not been shown to be safe and effective.” The FDA is concerned about purchasing medications online “from unregulated, unlicensed sources” because of the risk of “potentially unsafe products …”.
The FDA recommends that you use their “BeSafeRx campaign resources and tools…” Doing so enables you to make “safer, more informed decisions …”
They also encourage anyone who experiences an adverse event or quality problem to report the concern about “any medications to the FDA’s MedWatch Adverse Event Reporting program.”
The information for this blog was taken from the site www.fda.gov on June 2,2023.
Peter M. Hartmann, MD
Family Medicine & Psychiatry
