Exclusive-Suspected fake Ozempic linked to three US cases of hypoglycemia

Ozempic is displayed in a pharmacy in Provo

By Patrick Wingrove

(Reuters) -Three people sought medical treatment for dangerously low blood sugar in the U.S. last year after taking suspected fake versions of Novo Nordisk's diabetes drug Ozempic, America's Poison Centers told Reuters.

One person also experienced hypoglycemia in 2023 after injecting a compounded version of Ozempic, said the organization, which represents 55 regional poison centers across the country and works with the U.S. Food and Drug Administration 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 fueled a burgeoning global market for counterfeit versions.

Austrian and Lebanese health authorities last year reported that several people had suffered bouts of hypoglycemia after taking suspected fake Ozempic, some of whom were hospitalized.

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 Centers, formerly known as American Association of Poison Control Centers, said all three U.S. cases of suspected fake Ozempic were reported by the same regional poison control center, 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 centers.

In December, 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 Centers last year 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 hospitalization. Sixty-six of those reports involved hypoglycemia, and nearly all of them appeared to have used brand-name Ozempic, Brown said.

Brown added that most of those patients experiencing hypoglycemia went to the hospital for treatment.

Novo Nordisk lists hypoglycemia 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 Centers declined to say how the three cases of counterfeit semaglutide were identified. The group's regional centers sometimes receive that information from medical providers that treat the patients and obtain samples of the medicine, 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 U.S. 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 last year that it had found some samples of compounded semaglutide to be up to 33% impure.

(Reporting by Patrick Wingrove; Editing by Michele Gershberg, Bill Berkrot and Chizu Nomiyama)