The World Well being Group is warning the general public to avoid counterfeit Ozempic, or “fauxzempic.” The company has just lately obtained stories of medicine falsified to look just like the diabetes and off-label weight reduction drug Ozempic in at the very least three nations, together with the U.S.
The WHO issued a medical product alert concerning the pretend medicine Wednesday, together with a public announcement Thursday. The alert considerations three falsified batches found in three nations. Two batches have been detected final October in Brazil and the UK, respectively, whereas a 3rd batch was uncovered within the U.S. final December. All three have been reportedly confirmed as fraudulent by Ozempic’s producer, Novo Nordisk.
In a single lot, the product was labeled with a falsified batch quantity. In one other lot, the mixture of batch and serial numbers didn’t match official information. And within the third, the batch quantity was correct, however the precise product was falsified.
“WHO advises healthcare professionals, regulatory authorities and the general public pay attention to these falsified batches of medicines,” mentioned Yukiko Nakatani, WHO Assistant Director-Normal for Entry to Medicines and Well being Merchandise, in a statement from the company. “We name on stakeholders to cease any utilization of suspicious medicines and report back to related authorities.”
The lively ingredient in Ozempic is semaglutide, which is a part of a category of medicine often called incretins. Incretins work together with or mimic hormones that regulate our sense of starvation and blood sugar, amongst different features, with semaglutide being a mimic of GLP-1. In medical trials, semaglutide and different newer incretins have proven to be rather more efficient at treating weight problems than weight loss program and train alone. Ozempic is simply permitted for sort 2 diabetes, however a separate higher-dose model of semaglutide was permitted for weight problems underneath the identify Wegovy in 2021. Following Wegovy’s approval, Ozempic has grow to be routinely prescribed off-label for weight reduction as nicely.
Sadly, the demand for these medication has typically overwhelmed the provision. These shortages, mixed with excessive record costs (upwards of $1,000 a month) and low insurance coverage protection, has led to a gray and black market for the medication.
Some persons are acquiring their GLP-1s from compounded pharmacies, that are sometimes used to create custom-made medication for sufferers with particular wants, corresponding to medication freed from sure allergens. These pharmacies serve a legit goal and are alleged to supply their lively components from regulated amenities, however many locations promoting compounded semaglutide are doing so illegally, according to the Nationwide Affiliation of Boards of Pharmacy. Regulators have additionally begun to come back throughout counterfeit Ozempic made to seem like the actual deal. In at the very least some circumstances, the merchandise truly contained insulin and customers have been hospitalized with low blood sugar and seizures on account of overdosing on it.
Whereas these compounded and counterfeit medicines do are typically less expensive than the official model, at the very least with out insurance coverage protection, they’re riskier to take, given the dearth of regulation and oversight. The WHO is advising individuals who want these medication to acquire them from licensed physicians and to keep away from shopping for them from unfamiliar locations, significantly on-line pharmacies.
“Using falsified OZEMPIC could consequence within the ineffective remedy of sufferers resulting from incorrect dosage, contamination with dangerous substances, or use of unknown or substituted components. It could pose different severe dangers to well being due to its subcutaneous injection administration that might be life-threatening,” the WHO famous in its alert.