The Meals and Drug Administration said on Thursday that it had seized hundreds of items of counterfeit Ozempic, the diabetes drug additionally extensively used for weight reduction. Some fraudulent Ozempic merchandise should be available on the market, in accordance with the company.
The F.D.A. and Novo Nordisk, the corporate that makes Ozempic, are actually testing the seized medicines to find out what’s in them. Thus far, the company has confirmed that the needles accompanying these injectable medicines are counterfeit and will not be sterile. The labels, the packaging and the accompanying info for sufferers and well being care suppliers are additionally all fraudulent.
The company has linked 5 antagonistic occasions to a single lot of Ozempic that contained counterfeit remedy. Nevertheless, regulators haven’t decided if these points have been instantly brought on by the faux medicine; the signs have been just like widespread uncomfortable side effects of Ozempic, like nausea and abdomen ache.
The F.D.A. shared photos of the fake injectors and inspired sufferers to verify their remedy for indicators that it could possibly be counterfeit. For instance, an actual Ozempic needle ought to be coated by a paper tab that reads “NovoFine Plus,” whereas the counterfeit needles discovered thus far merely say “NovoFine.” Shoppers also can compare the lot and serial number of the remedy with these of the counterfeit medicine, or ask a pharmacist for assist figuring out that info.
It’s uncommon for a counterfeit drug to make it previous pharmacists or different safeguards and right into a affected person’s fingers, stated Shabbir Imber Safdar, the manager director of the Partnership for Secure Medicines, a nonprofit coalition that advocates defending customers in opposition to counterfeit and unsafe medicines.
However shortages can drive pharmacies to purchase from distributors they will not be aware of, he stated, placing them liable to shopping for counterfeits. Ozempic and related medicine have confronted provide challenges; some doses of Ozempic and Wegovy, which include the identical compound, are in short supply. And whereas the F.D.A. has strengthened its methods to trace and verify medicine throughout the provision chain, felony distributors have develop into more and more expert at making faux medicines that may bypass these obstacles, he added.
A consultant from Novo Nordisk wrote in an announcement that the counterfeit Ozempic merchandise have been seized “in warehouses exterior the Novo Nordisk licensed provide chain.” The F.D.A. stated that the counterfeit medicines had been discovered within the official drug provide chain.
There are additionally issues concerning the danger of counterfeit Ozempic coming from sources exterior that provide chain. As Ozempic and related medicine have grown more and more fashionable, there has “been an explosion of those totally different on-line distributors the place you may bypass a prescription altogether,” stated Dr. Scott Hagan, an assistant professor of medication on the College of Washington who research weight problems.
Medicine from a few of these direct-to-consumer web sites could come from the “gray market,” or unlicensed sellers that function exterior licensed networks, stated Timothy Mackey, a professor on the College of California, San Diego, who research counterfeit medicines. “Basically, what’s taking place is a grey market producer is solely assembly a market demand,” he stated. “And generally that product goes to be counterfeit or substandard.”
Counterfeit Ozempic has been a problem overseas as properly: Several people in Austria were hospitalized after utilizing counterfeit Ozempic, and 11 people in Lebanon developed dangerously low blood sugar after taking remedy that was believed to be faux, in accordance with Reuters.
The F.D.A. has additionally obtained reviews of antagonistic occasions amongst sufferers taking compounded versions of semaglutide, the substance in Ozempic. Well being officers have warned against utilizing these compounded medicines.
The company has urged folks to amass their remedy from state-licensed pharmacies. Usually, specialists say, it’s sensible to all the time receive Ozempic with a prescription and to be cautious of medication claiming to be Ozempic on the market at a far decrease price than the roughly $900 listing worth of the brand-name model.
“There isn’t a discount available for medication, together with Ozempic,” Mr. Safdar stated. “The cut price is hazard.”
