The World Well being Group is warning the general public to avoid counterfeit Ozempic or “fauxzempic”. The company just lately obtained experiences of counterfeit medicine showing to be the off-label diabetes drug and weight-loss drug Ozempic in not less than three international locations, together with the USA.
WHO launched medical product warning concerning the counterfeit drug on Wednesday, in addition to a public announcement on Thursday. The alert considerations three counterfeit shipments detected in three international locations. Two batches have been found in October final yr in Brazil and the UK respectively, whereas a 3rd batch was found within the US in December final yr. All three have been reportedly discovered to be fraudulent by Ozempic’s producer, Novo Nordisk.
One batch had a false batch quantity on the product label. In one other batch, the mix of batch quantity and serial quantity didn’t match the official information. And within the third, the batch quantity was correct, however the product itself was counterfeited.
“WHO encourages well being professionals, regulators and the general public to concentrate on these falsified drug shipments,” Yukiko Nakatani, WHO assistant director-general for entry to medicines and well being merchandise, stated within the report. assertion from the company. “We urge stakeholders to cease any use of suspected medicine and report this to the related authorities.”
The lively ingredient in Ozempic is semaglutide, which is a part of a category of medicine generally known as incretins. Incretins work together with or mimic hormones that regulate our starvation and blood sugar ranges, amongst different capabilities, with semaglutide being a GLP-1 mimic. In scientific research, semaglutide and different new incretins have proven verified be a way more efficient therapy for weight problems than weight loss program and train alone. Ozempic is authorised just for the therapy of kind 2 diabetes, however a separate higher-dose model of semaglutide known as Wegovy was authorised in 2021 for the therapy of weight problems. Since Wegovy’s approval, Ozempic has been routinely prescribed off-label and for weight reduction.
Sadly, the demand for these medicine typically exceeds the availability. This scarcity, coupled with excessive checklist costs (over $1,000 per 30 days) and low insurance coverage protection, has led to grey and black market for medicine.
Some individuals buy GLP-1 from pharmacies, that are generally used to create personalized medicines for sufferers with particular wants, equivalent to medicines that don’t comprise sure allergens. These pharmacies serve a respectable function and should get hold of lively elements from regulated amenities, however many locations that promote compounded semaglutides achieve this illegally. in line with to the Nationwide Affiliation of Boards of Pharmacy. Regulators have additionally begun to come across counterfeits of Ozempic that appear to be the true factor. In not less than some instances, the merchandise did comprise insulin, and customers have been hospitalized with low blood sugar and seizures because of an overdose.
Whereas these compounded and counterfeit medicines are usually less expensive than the official model, not less than with out insurance coverage, they’re riskier to take given the shortage of regulation and oversight. WHO advises individuals who want these medicines to buy them from licensed docs and keep away from buying from unfamiliar locations, particularly on-line pharmacies.
“Using counterfeit OZEMPIC might end in ineffective therapy for sufferers resulting from incorrect dosage, contamination with dangerous substances, or using unknown or substituted elements. It might pose different critical well being dangers resulting from subcutaneous administration, which can be life-threatening,” WHO stated in its warning.