Ten people have died and 100 have been hospitalized after taking pharmacy-made copycat versions of Ozempic, its manufacturer has revealed.
These compounded weight loss drugs, which are often cheaper, were sold by ‘med spas’ and pharmacies during nationwide shortages of the branded drugs over the last two years.
Ozempic maker Novo Nordisk claims these off-brand versions of its drugs are made with little regulation or oversight which raises the risk that someone could fall ill after using them.
Few details on the patients have been revealed, including their locations, ages or the adverse reactions they suffered.
But the FDA said reactions to compounded versions are often linked to overdosing or people accidentally administering the wrong dose, which may lead people to be hospitalized for complications including nausea, vomiting, diarrhea, abdominal pain and constipation.
Experts have also previously warned that an overdose can leave someone at risk of seizures and even a coma — because the drug can trigger very low blood sugar.
Novo revealed the cases after asking the FDA to ban compounded versions of its drugs Ozempic and Wegovy last month. It says they are too complicated to be made by pharmacies.
The weight loss medications, which use the drug semaglutde, have been in shortage for more than two years in the US after a Hollywood-charged surge in use for their promise to help someone lose weight with nothing more than a weekly injection.
Compounded versions of Ozempic, those made by pharmacies, have been linked to deaths
The FDA still has to make a final decision on whether to ban compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy.
US regulations allow pharmacies to make their own, or compounded, versions of branded drugs when they are out of stock in order to fill prescriptions.
Supporters say this is necessary to ensure people continue to receive potentially life-saving medication and keep up with doses.
But, arguing against the practice for Ozempic, Novo Nordisk CEO Lars Fruergaard Jorgensen said it was ‘puzzling’ that people in the US were being allowed to inject themselves with a product that was not regulated, approved or inspected.
‘It beats me up’, 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 ‘health spas’, rather than through the formal supply chain, Novo Nordisk said.
It has also been investigating a number of compounded products which it says have multiple safety concerns, although these were not detailed.
The Novo Nordisk tally is lower than the FDA’s, with the agency saying it had received 346 reports of adverse events linked to compounded semaglutide by the end of August this year. It did not give a figure 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’s adverse events reporting system (FAERS) — which was 94 at the start of September this year.
The system only suggests a link, and does not definitively prove that the fatalities were caused by the medication.
Trish Webster, 56, from Australia, died after injecting herself with Ozempic to lose weight for her daughter’s wedding. She is pictured above with her husband Roy
There were also 68 deaths linked to tirzepatide, the drug used in weight loss shots Mounjaro and Zepbound.
Novo Nordisk has now ramped up production to meet demand in the US, with all of its Wegovy and Ozempic now back in stock nationwide.
But the drugs still remain on the FDA’s shortage list, allowing pharmacies to continue to make compounded versions.
Novo Nordisk chief financial officer Karsten Munk Knudsen said: ‘This is an ongoing dialogue with the FDA.
‘I don’t want to speculate tody whether we’re completely off the shortages list, but this is a first step and we’re hopeful that we’ll be getting off in future.’
Nearly five million Americans were prescribed semaglutide in 2023, according to Penn Medicine, with four in ten using it for weight loss.
One month of Ozempic costs $935.77-a-month out of pocket, while a month’s supply of Wegovy costs up to $2,000.
