Ten people have died and 100 have been hospitalized after taking imitation versions of Ozempic made in pharmacies, its manufacturer has revealed.
These compounded weight-loss medications, which are often cheaper, were sold in ‘medical spas’ and pharmacies during nationwide shortages of brand-name medications over the past two years.
Ozempic’s maker, Novo Nordisk, says these off-brand versions of its drugs are made with little regulation or oversight, increasing the risk of someone getting sick after using them.
Few details have been revealed about the patients, including their location, ages or the adverse reactions they suffered.
But the FDA said reactions to the compounded versions are often linked to overdoses 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 leave someone at risk of seizures and even coma, because the medication can cause very low blood sugar levels.
Novo revealed the cases after asking the FDA to ban compounded versions of its drugs Ozempic and Wegovy last month. He says they are too complicated for pharmacies to make.
Weight loss medications, which use the drug semaglude, have been in shortage for more than two years in the US after a surge in use accused by Hollywood for its 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 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 so they can fill prescriptions.
Supporters say this is necessary to ensure people continue receiving potentially life-saving medications and stay up to date on doses.
But, arguing against Ozempic’s practice, Novo Nordisk CEO Lars Fruergaard Jorgensen said it was “baffling” that people in the United States were 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 that it claims have multiple safety issues, although these were not detailed.
Novo Nordisk’s count is lower than the FDA’s, and the agency said it had received 346 reports of adverse events related to the compounded semaglutide as of late August of this year. He did not give a death toll.
It is also lower than the number of deaths related to semaglutide, the drug used in Wegovy and Ozempic, reported in the FDA’s adverse event reporting system (FAERS), which was 94 at the beginning of September this year.
The system only suggests a link and does not definitively prove that the deaths were caused by the drug.
Trish Webster, 56, from Australia, died after taking Ozempic injection 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 the Mounjaro and Zepbound weight loss injections.
Novo Nordisk has now increased production to meet demand in the US, and all of its Wegovy and Ozempic are now back in stock nationwide.
But the drugs still remain on the FDA’s shortage list, allowing pharmacies to continue making compounded versions.
Novo Nordisk CFO Karsten Munk Knudsen said: ‘This is an ongoing dialogue with the FDA.
“I don’t want to speculate today whether we are completely off the shortage list, but this is a first step and we are hopeful of getting off in the future.”
According to Penn Medicine, nearly five million Americans were prescribed semaglutide in 2023, and four in ten used it to lose weight.
A month of Ozempic costs $935.77 a month out of pocket, while Wegovy’s monthly supply costs up to $2,000.