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Suspected fake Ozempic linked to three US cases of hypoglycemia

Last year, three people reportedly sought medical treatment for dangerously low blood sugar in the US after taking suspected fake versions of Novo Nordisk’s diabetes drug Ozempic.

Ozempic and other drugs that target diabetes have also become popular in the medical community as a treatment for weight loss. As a result, demand for similar drugs has skyrocketed, with medications including Eli Lilly’s Zepbound and Novo’s Wegovy being approved to treat weight loss. However, this has led to a growing market for counterfeit versions of the drugs.

Hypoglycemia is listed by Novo Nordisk as a potential side effect of Ozempic, especially for diabetes patients who use the drug in tandem with insulin to manage blood glucose levels. According to the label, symptoms of headaches or dizziness can potentially lead to a loss of consciousness or seizures.

America’s Poison Centers - which represents 55 regional poison centers across the country and works with the US Food and Drug Administration - told Reuters that three patients experienced hypoglycemia in 2023 after being injected with counterfeit Ozempic, and one experienced symptoms after an injection of a compounded version of Ozempic.

The organisation received 3,316 reports last year from people using different versions of Ozempic, more than double the previous year, clinical managing director Kaitlyn Brown explained to the outlet. Brown added that the majority of reports consisted of minor side effects of the drug, including nausea and vomiting that went unhospitalised. Sixty-six of those reports involving complaints of hypoglycemia were mostly attributed to the use of real Ozempic. The clinical managing director noted that the majority of patients experiencing symptoms of hypoglycemia went to the hospital.

All three US cases of suspected fake Ozempic were reported by the same regional poison control center, according to the organisation. The Food and Drug Administration (FDA) was reportedly investigating the claims. At the time, the FDA said they had received reports saying that the patients had taken both the compounded and counterfeit semaglutide products, however, the organisation added that they do not comment on ongoing investigations.

Compounded products are custom-made medicines based on the same ingredients as branded drugs like Ozempic, but can be licensed and legally produced by pharmacies across the US if the branded version of the drug is in short supply. Compounded medicines are often less expensive to produce, but on the flip side are under less scrutiny from the likes of the FDA.

In December, the FDA reportedly seised “thousands of units” of counterfeit Ozempic during an ongoing investigation but at the time did not report any cases that suggested anyone had been seriously harmed by the counterfeit drugs.

According to Austrian and Lebanese health authorities, several people the previous year suffered from hypoglycemia after taking what they suspected was fake Ozempic. Some of these individuals were reportedly hospitalised.

An Austrian health regulator reported that the fake Ozempic was believed to have contained insulin instead of semaglutide, a crucial and active ingredient in the formula of Ozempic and other diabetes drugs. Meanwhile, another drug regulator from Belgium confirmed that authorities had seized counterfeit Ozempic containing insulin.