A particular formulation of semaglutide is presenting hazards that a major pharmaceutical company is warning customers about.
Experts: A Popular Weight Loss Drug Has Caused 10 Deaths—What Consumers Should Know
World events and a national election have taken precedent over earlier headlines related to the popularity of emerging injectable weight loss drugs. Last May, a Kaiser Family Foundation survey found that one in eight American adults—that’s 13% of the population—has tried a GLP-1 agonist to manage their weight or treat type 2 diabetes.
A caution for those one in eight: On Wednesday, November 6, Ozempic manufacturer Novo Nordisk released a statement warning that compounded versions of semaglutide, the active ingredient in many injectable weight loss medications, have contributed to more than 100 hospitalizations and 10 deaths to date.
The “compounded” version of a drug means that it’s a formula designed to be mixed in a compounding pharmacy—making it a less expensive and more widely available alternative to GLP-1 drugs. However, the FDA explains that the compounded semaglutide products are “not reviewed” and “not approved.”
Typically, the FDA explains, drugs are compounded when a patient “cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.”
In the case of semaglutide and tirzepatide—the latter being the active ingredient found in Ozempic competitors like Mounjaro and Zepbound—compounded drugs have been developed to sidestep product shortages, some of which are ongoing.
In August of this year, the FDA noted that it had received 346 reports of adverse events with compounded semaglutide and 136 reports of adverse events with compounded tirzepatide, though only some of these were severe enough to require hospitalization. Representatives of Novo Nordisk say that they are tracking hospitalizations and deaths in collaboration with the FDA—as Novo Nordisk President and CEO Lars Fruergaard Jorgensen told CNN earlier this week: “Honestly, I’m quite alarmed by what we see in the U.S. now. Patients who believe that they’re getting access to a safe product, and they believe they’re getting semaglutide … I know for a fact that they are not getting semaglutide, because there’s only one semaglutide, and that’s produced by Novo Nordisk, and we don’t sell that to others.”
The FDA explains that that dosing errors tend to be main factor in these events, though there are several other concerns.
Additionally, certain formulations of compounded GLP-1 medications pose a danger—namely, those made with the experimental drug Retatrutide and those made with salt forms of semaglutide. “These salt forms, including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs,” the FDA says.
Illegally marketed knockoffs of brand-name drugs also continue to raise alarms. The FDA warns these are considered counterfeit and fraudulent and “could contain the wrong ingredients, contain too little, too much or no active ingredient at all or other harmful ingredients.”
Individuals who choose to take compounded drugs should work closely with their licensed and certified healthcare provider to determine safe doses and dosing schedules, and to monitor for potential adverse effects. Patients looking for more safety assurances should seek FDA-approved drugs indicated for the patient’s health condition.
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