Ten people have died and 100 have been hospitalized after taking pharmacy-made copycat versions of Ozempic, the manufacturer has revealed.
These compounded weight-loss medications, which are often cheaper, were sold by medical spas and pharmacies over the past two years during nationwide shortages of brand-name drugs.
Ozempic maker Novo Nordisk claims that these off-brand versions of its drugs are made with little regulation or oversight, which increases the risk of someone getting sick after using them.
Few details have been revealed about the patients, including their location, age or the side effects they experienced.
But the FDA said reactions to compounded versions are often linked to overdose or people accidentally giving the wrong dose, which can lead to people being hospitalized for complications such as nausea, vomiting, diarrhea, abdominal pain and constipation.
Experts have also previously warned that an overdose can put someone at risk of seizures and even a coma, as the drug can cause very low blood sugar levels.
Novo disclosed the cases after asking the FDA last month to ban compounded versions of its drugs Ozempic and Wegovy. It says they are too complicated for pharmacies to make.
The weight loss drugs, which use the drug semaglutde, have been in short supply in the U.S. for more than two years after a surge in use denounced by Hollywood for their promise to help a person lose weight with nothing more than a weekly injection.
Compounded versions of Ozempic, made by pharmacies, have been linked to deaths
The FDA has yet to make a final decision on whether to ban compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy.
U.S. regulations allow pharmacies to make their own or compounded versions of brand-name drugs when they are out of stock to fill prescriptions.
Advocates say this is necessary to ensure people continue to receive potentially life-saving medications and can keep track of doses.
But as an argument against the practice for Ozempic: Novo Nordisk CEO Lars Fruergaard Jorgensen said it was “baffling” that people in the US were allowed to inject themselves with a product that was not regulated, approved or inspected.
“It catches me by surprise,” he said in an interview with Reuters, before adding: “I think this is something that will change over time.”
Copycat versions were often sold online and through so-called “spas”, rather than through the formal supply chain, Novo Nordisk said.
It has also investigated a number of compounded products that it says have multiple safety concerns, although these are not detailed.
Novo Nordisk’s figure is lower than the FDA’s, with the agency saying it had received 346 reports of adverse events linked to compound semaglutide by the end of August this year. It did not provide figures for fatalities.
It is also lower than the number of deaths linked to semaglutide, the drug used in Wegovy and Ozempic, reported in the FDA Adverse Event Reporting System (FAERS) – which stood at 94 as of early September this year.
The system only suggests a connection and does not definitively prove that the fatalities were caused by the medication.
Trish Webster, 56, from Australia, died after giving herself an injection of Ozempic to lose weight before her daughter’s wedding. She is pictured above with her husband Roy
There were also 68 deaths linked to tirzepatide, the drug used in slimming shots Mounjaro and Zepbound.
Novo Nordisk has now ramped up production to meet US demand, with all of its Wegovy and Ozempic now back in stock nationwide.
But the drugs are still on the FDA’s shortage list, allowing pharmacies to continue making compounded versions.
Karsten Munk Knudsen, chief financial officer of Novo Nordisk, said: “This is an ongoing dialogue with the FDA.
“I don’t want to speculate today on whether we have been completely removed from the deficit list, but this is a first step and we are hopeful that we can get rid of it in the future.”
According to Penn Medicine, nearly five million Americans were prescribed semaglutide in 2023, with four in 10 using it for weight loss.
A month’s worth of Ozempic costs $935.77 per month out of pocket, while a month’s supply of Wegovy costs up to $2,000.