UNITED STATES - Three people sought medical treatment for dangerously low blood sugar in the United States in 2023 after taking suspected fake versions of Novo Nordisk’s diabetes drug Ozempic, America’s Poison Centres told Reuters.
One person also experienced hypoglycaemia in 2023 after injecting a compounded version of Ozempic, said the organisation, which represents 55 regional poison centres across the country and works with the US Food and Drug Administration (FDA) to identify public health risks.
Ozempic and similar diabetes medicines have been increasingly used off label for weight loss. Explosive demand for Ozempic and other drugs approved for weight loss, including Eli Lilly’s Zepbound and Novo’s Wegovy, has fuelled a burgeoning global market for counterfeit versions.
Austrian and Lebanese health authorities in 2023 reported that several people had suffered bouts of hypoglycaemia after taking suspected fake Ozempic, some of whom were hospitalised.
The Austrian health regulator said the products likely contained insulin instead of Ozempic’s actual active ingredient, semaglutide. Belgium’s drug regulator confirmed that some counterfeit Ozempic seized in that country contained insulin.
America’s Poison Centres, formerly known as American Association of Poison Control Centres, said all three US cases of suspected fake Ozempic were reported by the same regional poison control centre, and that the FDA was investigating, without providing further details.
The FDA said it had received adverse event reports after patients took both compounded and counterfeit semaglutide products, but that it does not generally comment on ongoing investigations. Semaglutide is also the active ingredient in Wegovy.
Novo Nordisk said it did not have insight into the details of these cases because they were reported directly to the poison control centres.
In December 2023, the FDA said it had seized “thousands of units” of counterfeit Ozempic in an investigation that was ongoing but did not report cases in which people were seriously harmed by the drugs at the time.
America’s Poison Centres in 2023 received 3,316 reports from people taking versions of Ozempic, more than double the previous year, said clinical managing director Kaitlyn Brown.
Most were non-serious complaints of symptoms known to be side effects of the drug, such as nausea and vomiting that did not require hospitalisation. Sixty-six of those reports involved hypoglycaemia, and nearly all of them appeared to have used brand-name Ozempic, Dr Brown said.
Dr Brown added that most of those patients experiencing hypoglycaemia went to the hospital for treatment.
Novo Nordisk lists hypoglycaemia as a potential side effect of Ozempic. That risk increases for diabetes patients who use the drug along with insulin to manage blood glucose levels, its label says. Symptoms include headaches or dizziness and can progress to a loss of consciousness or seizures.
America’s Poison Centres declined to say how the three cases of counterfeit semaglutide were identified. The group’s regional centres sometimes receive that information from medical providers that treat the patients and obtain samples of the medicine, Dr Brown said.
While fake drugs often do not contain any of the medication advertised, compounded drugs are custom-made medicines that are based on the same ingredients as branded drugs. They can be legally produced by licensed pharmacies in the US when the branded version of the drug is in short supply.
Compounded medicines are often less expensive, but also subject to less regulatory scrutiny.
Novo Nordisk reported late in 2023 that it had found some samples of compounded semaglutide to be up to 33 per cent impure. REUTERS
