Suspected fake Ozempic linked to three US cases of hypoglycemia

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Last 12 months, three individuals reportedly sought medical therapy for dangerously low blood sugar within the US after taking suspected fake variations of Novo Nordisk’s diabetes drug Ozempic.

Ozempic and different medication that focus on diabetes have additionally develop into standard within the medical group as a therapy for weight reduction. As a consequence, demand for related medication has skyrocketed, with medicines together with Eli Lilly’s Zepbound and Novo’s Wegovy being authorized to deal with weight reduction. However, this has led to a rising marketplace for counterfeit variations of the medication.

Hypoglycemia is listed by Novo Nordisk as a possible aspect impact of Ozempic, particularly for diabetes sufferers who use the drug in tandem with insulin to handle blood glucose ranges. According to the label, signs of complications or dizziness can probably lead to a loss of consciousness or seizures.

America’s Poison Centers – which represents 55 regional poison facilities throughout the nation and works with the US Food and Drug Administration – advised Reuters that three sufferers skilled hypoglycemia in 2023 after being injected with counterfeit Ozempic, and one skilled signs after an injection of a compounded model of Ozempic.

The organisation acquired 3,316 reviews final 12 months from individuals utilizing totally different variations of Ozempic, greater than double the earlier 12 months, medical managing director Kaitlyn Brown defined to the outlet. Brown added that almost all of reviews consisted of minor uncomfortable side effects of the drug, together with nausea and vomiting that went unhospitalised. Sixty-six of these reviews involving complaints of hypoglycemia had been principally attributed to the use of actual Ozempic. The medical managing director famous that almost all of sufferers experiencing signs of hypoglycemia went to the hospital.

All three US cases of suspected fake Ozempic had been reported by the identical regional poison management heart, in accordance to the organisation. The Food and Drug Administration (FDA) was reportedly investigating the claims. At the time, the FDA mentioned they’d acquired reviews saying that the sufferers had taken each the compounded and counterfeit semaglutide merchandise, nevertheless, the organisation added that they don’t touch upon ongoing investigations.

Compounded merchandise are custom-made medicines primarily based on the identical substances as branded medication like Ozempic, however will be licensed and legally produced by pharmacies throughout the US if the branded model of the drug is in brief provide. Compounded medicines are sometimes inexpensive to produce, however on the flip aspect are beneath much less scrutiny from the likes of the FDA.

In December, the FDA reportedly seised “thousands of units” of counterfeit Ozempic throughout an ongoing investigation however on the time didn’t report any cases that advised anybody had been significantly harmed by the counterfeit medication.

According to Austrian and Lebanese well being authorities, a number of individuals the earlier 12 months suffered from hypoglycemia after taking what they suspected was fake Ozempic. Some of these people had been reportedly hospitalised.

An Austrian well being regulator reported that the fake Ozempic was believed to have contained insulin as an alternative of semaglutide, a vital and energetic ingredient within the formulation of Ozempic and different diabetes medication. Meanwhile, one other drug regulator from Belgium confirmed that authorities had seized counterfeit Ozempic containing insulin.