Off-brand Ozempic leaves 10 dead, 100 hospitalized
Key Takeaways
The CEO of Novo Nordisk has reported that there have been at least 100 hospitalizations and 10 deaths due to compounded versions of semaglutide.
The FDA has cautioned that adverse events have been reported due to compounded versions, including problems with compounded dosing being higher than that approved by the FDA.
The FDA cautions healthcare providers prescribing compounded versions of semaglutide to be vigilant with dosing, titration, and dosing schedules.
The CEO of Novo Nordisk has warned that compounded versions of semaglutide have been associated with at least 100 hospitalizations and 10 deaths.[]
The active ingredient is found in medications approved for both weight loss and diabetes, but the only version approved by the US Food and Drug Administration (FDA) is manufactured by Novo Nordisk.
“Honestly, I’m quite alarmed by what we see in the US now,” President and CEO of Novo Nordisk Lars Fruergaard Jørgensen told CNN.
“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.”
Compounded drugs are sometimes produced by pharmacies or providers other than those that make FDA-approved versions of the medications and are typically allowed when there are drug shortages.
Semaglutide shortage
As of October 2, 2024, semaglutide is in shortage, per the FDA.[]
In early October, the FDA released a statement citing concern over unapproved GLP-1 drugs being used for weight loss, including compounded versions.[]
FDA response
“A compounded drug might be appropriate if a patient’s medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available. However, compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed,” the FDA stated.
“The agency has identified some areas of concern for compounded GLP-1 drugs … FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products. These dosing errors resulted from patients measuring and self-administering incorrect doses of the drug, and in some cases, health care professionals miscalculating doses of the drug.”
Patients may seek compounded drugs online
Mir Ali, MD, a board-certified general surgeon, bariatric surgeon, and Medical Director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, says that while there are some reputable providers of compounded semaglutide, some patients may look to unsafe online sources.
“You have to get [compounded versions] from a legitimate source and legitimate pharmacy because if it's a legitimate pharmacy distributed by [a] legitimate source, usually they’re safe. But sometimes people are getting them online through social media and other sources, [and] then [they’re] taking more of a risk,” Dr. Ali says.
"Sometimes they can be ineffective—it's not the actual medication—but other times they could actually have some harmful materials in [them] that could cause a problem."
— Mir Ali, MD
As of August 31, 2024, 346 adverse events with compounded semaglutide have been reported to the FDA.[]
Under federal law, however, state-licensed pharmacies that aren’t outsourcing facilities are not required to submit records of adverse events to the FDA. The true number of adverse events is therefore likely higher.
The FDA says that healthcare providers should be vigilant when prescribing compounded versions of semaglutide and determining appropriate doses, titration, and dosing schedules.
Understanding the risk
“I've always cautioned my patients against compounding pharmacies for semaglutide,” Dan Azagury, MD, FACS,, Section Chief of Minimally Invasive and Bariatric Surgery at Stanford University, tells MDLinx. A compounded version of semaglutide is not something he recommends to his patients.
“Is it possible that it's safe? Yes. Do you want to take that chance? I don't ... It's important to explain to patients that they have to have a little bit of patience on this—that ultimately we will be able to get them on the drug if their insurance approves it, and then it's just a matter of time. There is no reason to take a gamble on your health with a compounded drug to get it sooner,” Dr. Azagury adds.
What this means for you
At least 100 hospitalizations and 10 deaths have been linked to compounded versions of semaglutide. The active ingredient is found in weight loss medications, but the only FDA-approved version is the one made by Novo Nordisk. The FDA has expressed concerns about adverse events due to compounded versions, including patients taking compounded versions at higher doses than those approved by the FDA. The agency says that healthcare providers should be vigilant when prescribing compounded versions of semaglutide and determining dosing, titration, and dosing schedules.