Last year, three individuals in the United States sought medical treatment for dangerously low blood sugar after taking suspected counterfeit versions of Novo Nordisk’s diabetes drug Ozempic, according to America’s Poison Centers. The organization, representing regional poison centers nationwide, works with the U.S. Food and Drug Administration (FDA) to identify public health risks.
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In an exclusive by Reuters, counterfeit versions of Ozempic and similar diabetes medications have become increasingly prevalent due to their off-label use for weight loss. The demand for Ozempic and other weight loss drugs, such as Eli Lilly’s Zepbound and Novo’s Wegovy, has created a booming global market for counterfeit drugs. Last year, Austrian and Lebanese health authorities reported cases of hypoglycemia in individuals who had taken suspected counterfeit Ozempic, some of whom required hospitalization. The Austrian health regulator suggested that the counterfeit products contained insulin instead of Ozempic’s active ingredient, semaglutide. Belgian drug regulators also confirmed the presence of insulin in some seized counterfeit Ozempic.
America’s Poison Centers revealed that the same regional poison control center reported all three cases of suspected counterfeit Ozempic in the U.S.. The FDA is investigating the incidents, but no further details were provided. The FDA acknowledged receiving adverse event reports on compounded and counterfeit semaglutide products. However, the agency typically does not comment on ongoing investigations. Semaglutide is also the active ingredient in Wegovy.
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Novo Nordisk stated that it did not have specific information about the reported cases as they were directly reported to the poison control centers.
In December, the FDA announced that it had seized “thousands of units” of counterfeit Ozempic as part of an ongoing investigation. At that time, no cases of serious harm resulting from the use of counterfeit drugs had been reported. America’s Poison Centers received 3,316 reports related to Ozempic last year, more than double the previous year. Most of these reports involved non-serious complaints of known side effects, such as nausea and vomiting, which did not require hospitalization. Sixty-six reports involved hypoglycemia, with the majority of patients having used brand-name Ozempic.
Novo Nordisk acknowledges hypoglycemia as a potential side effect of Ozempic, mainly when used alongside insulin to manage blood glucose levels. Symptoms of hypoglycemia include headaches, dizziness, and, in severe cases, loss of consciousness or seizures. America’s Poison Centers did not disclose how the three cases of counterfeit semaglutide were identified. Regional centrs often receive such information from medical providers treating the patients and obtaining medication samples.
The lack of accessibility to Ozempic due to the drug being used as a method of rapid weight loss has been a subject of controversy, especially among celebrities in Hollywood. Many have been accused of buying massive amounts of diabetic medication to have quick results. There have been reports of the average citizen falling ill due to the severe side effects of the drug, such as the case of a young woman who allegedly suffered a bowel injury due to continuous use of the drug. It is worth noting that while counterfeit drugs typically do not contain the advertised medication, compounded drugs are custom-made medicines that use the same ingredients as branded drugs. Compounded drugs can be legally produced by licensed pharmacies in the U.S., mainly when the branded version of the drug is in short supply. However, compounded drugs undergo less regulatory scrutiny compared to their branded counterparts.