Counterfeit Ozempic warning issued after FDA seizes 1000’s of items
The U.S. Meals and Drug Administration is advising further warning after seizing 1000’s of items of counterfeit Ozempic, in keeping with a discover issued Thursday.
The imitation medicines have been related to 5 circumstances of sickness up to now, mentioned the company, however none have been reported as severe. Those that used counterfeit doses have reported adversarial reactions according to the genuine product, together with nausea, vomiting, diarrhea, stomach ache and constipation.
Whereas the FDA and Ozempic’s producer, Novo Nordisk, have already collected and are testing 1000’s of samples, they’ve warned that some counterfeit merchandise should be obtainable for buy.
Due to this, wholesalers, retail pharmacies, well being care practitioners and sufferers alike are suggested to examine any semaglutide they’ve obtained to make sure they don’t seem to be a part of the bogus provide, which is labeled with lot quantity NAR0074 and serial quantity 430834149057.
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Preserve an eye fixed out for counterfeits
The FDA and Novo Nordisk are at the moment testing collected samples to find out their contents, security and efficacy. Up to now, they’ve decided that the merchandise’ pen labels, well being care skilled and affected person info and the carton by which the medicine comes have been all counterfeit.
Importantly, the needles have been additionally discovered to be counterfeit, which means their sterility can’t be confirmed and will pose an elevated danger of an infection to sufferers.
Anybody at the moment in possession of a semaglutide product is suggested to take a detailed look earlier than utilizing, promoting or in any other case distributing it to substantiate not solely the lot and serial numbers, but additionally the labeling and packaging it is available in. The FDA encourages customers to check pictures posted to their web site of genuine Ozempic packaging to the merchandise of their provide for variations in shade, labels and total look.
The company additionally reminded pharmacies to buy Ozempic solely by way of approved Novo Nordisk distributors and sufferers solely to acquire it by way of a prescription from a state-licensed pharmacy. Everybody dealing with the product is suggested to look it over rigorously for indicators of tampering or counterfeit.
What’s Ozempic (semaglutide)?
What’s Ozempic:You’ve got heard of Ozempic, however do you perceive the way it works?
Weight reduction medicine grew to become one of many hottest matters in well being in 2023. Initially supposed to handle diabetes, the preferred drug, semaglutide, has garnered large recognition for its skill to advertise fast weight reduction in sufferers.
Semaglutide is the generic title for Wegovy, which is permitted for weight reduction, and Ozempic, which is used to deal with diabetes. Each are made by Novo Nordisk.
Ozempic works by mimicking the hormone GLP-1, which helps the pancreas launch insulin. It promotes weight reduction by sending indicators to the urge for food middle in your mind to scale back starvation and improve fullness, making it simpler to handle starvation cues, follow smaller and fewer meals and overcome emotional or boredom consuming.
Semaglutide has been proven to assist sufferers lose 15% to twenty% of their physique weight however can be expensive and sometimes not lined by insurance coverage if used primarily for weight-loss functions.
Costing round $1,000 a month for weekly injections, the medicine have additionally been proven to current some severe downsides, one among which is the tendency for customers to place the burden again on after stopping therapy. There’s additionally a low danger of pancreatitis, gallstone illness and gastroparesis.
Ozempic shortages
Semaglutide has been in brief provide for about two years, largely as a result of it has been more and more prescribed off-label to individuals who haven’t got diabetes.
Whereas Ozempic was permitted for the therapy of diabetes again in 2017, Wegovy was solely permitted to be used in weight reduction in 2021, inflicting an explosion in demand.
As beforehand reported by USA TODAY, Novo Nordisk has struggled to maintain up with the massive demand, as knowledge launched in September confirmed that prescriptions skyrocketed in main metropolitan areas inside the first 12 months of Wegovy’s approval. In some places, resembling Cleveland and Seattle, prescriptions for semaglutide went up 481% and 351%, respectively.
