August 22, 2023 – In horse racing, a “false favorite” is a horse whose odds don't reflect its ability and is unlikely to deliver. The same goes for fake or counterfeit versions of the drug semaglutide, sold as Wegovy for weight reduction and Ozempic for type 2 diabetes, that are flooding the North American and global markets.
The temptation is great and 1000's risk their health to get these products by any means mandatory. Even some doctors are involved within the shell game, although the possibilities (and safety) are superb.
Over the past two years, the surge in interest and recognition catapulted Wegovy from obesity clinics into the world of Hollywood stars and TikTok influencers. The result has been a boon for Danish drugmaker Novo Nordisk, together with production issues as a result of limited supplies, shortages and an increase in counterfeits.
While Novo Nordisk legal action against medical spas, weight reduction and wellness clinics and even Compounding pharmaciesCase reports describe administration errors and accidental overdoses, calls to poison control hotlines, and visits to hospital emergency rooms.
For hundreds of thousands of patients who rely on access to those medicines, caution is suggested: How can a counterfeit be distinguished from the unique?
“We have received calls about several of these cases,” said Jimmy Leonard, PharmD,Director of Clinical Services on the Maryland Poison Center on the University of Maryland School of Pharmacy in Baltimore. “We have seen people overdose tenfold on one attempt,” he said.
“Boy, were they sick.”
Amber Johnson, PharmD, director of the Utah Poison Control Center and assistant professor of pharmacy on the University of Utah in Salt Lake City, said, “We have actually received as many reports so far as we have in 2022,” noting that the majority Calls as a result of cumulative errors.
Compounded drugs will not be approved by the FDA, but they're allowed to be produced during an official drug shortage. Ozempic and Wegovy are currently on the FDA's shortage drug list, however the federal agency warned in May that it had received reports of individuals experiencing “adverse reactions” after taking compounded versions of those drugs.
Johnson, co-author of a semaglutide case series published end of Junesaid there have been greater than 3 times as many cases of accidental administration errors and antagonistic events related to semaglutide in 2022 than in 2021.
Overall, poison control centers across the country are reporting an increasing variety of such cases, which Johnson says is cause for concern.
“Because of these errors, people are suffering from long-lasting side effects that have sent some of them to the emergency room,” she said.
Compounding vs. Counterfeiting
In its warning in May, the FDA said some products sold under the name semaglutide may not contain the identical energetic ingredient because the FDA-approved version, but relatively a salt form whose safety or effectiveness has not been established.
Novo Nordisk (which declined to talk to WebMD) followed a couple of weeks later with its own statement: Alerting the public that a counterfeit formulation of Ozempic was circulating within the United States. This version contained a long-acting type of insulin and resulted in a side effect. In each cases, the culprits were pharmacies that manufactured the drugs themselves.
Compounding is the strategy of making a customized type of a drug to satisfy a selected need (for instance, removing a substance to which a patient could also be allergic, reminiscent of lactose or a dye).
Because compounded drugs don't require FDA review, they will carry certain risks, especially if the pharmacist making the mixture doesn't have access to the actual FDA-approved component, which on this case is a patented chain of amino acids or proteins that cross the blood-brain barrier. This unique property is a giant reason why Wegovy works so well for chronic weight reduction—it targets an element of the brain that regulates appetite. It's also a giant reason why it's in such high demand.
Susan M., a 45-year-old journalist from Texas who gained 100 kilos after giving birth to her second child, said that taking Wegovy helped her accept and understand the disease strategy of obesity in a way she hadn't before.
“It wasn't until I started taking this medication that I thought of it in the same way that I would think of a blood sugar medication or a blood pressure medication or something like that,” she said. “What blew me away was the absence of 'eating noises,' as if food was always on the periphery of your thoughts,” she said.
Experts in the sector of obesity medicine agree on the unique properties and effectiveness of the drug.
“With older drugs, only about 10% of people were able to lose 20% of their weight. With semaglutide, 40% of people can now achieve that 20% weight loss, which is why the demand for it is so high,” said Dr. Angela Fitch, chief medical officer of healthcare company Knownwell and president of the Obesity Medicine Association.
However, Fitch also identified that “every compounded product today is counterfeit. The base source does not come from companies that are legally allowed to manufacture it and there is no control over it. It is like [the television show] breaking Bad”, she said.
Mind you, compounding just isn't illegal; the method is permitted – especially during drug shortages – so long as certain quality control and other requirements of the Federal Food, Drug and Cosmetic Act are met. Currently, Novo Nordisk is the one company within the U.S. that holds the patents for Ozempic and Wegovy, and there are not any FDA-approved generic versions of semaglutide. This signifies that any Ozempic or Wegovy you get at a compounding pharmacy, medical spa, or online just isn't the unique, has not been thoroughly tested or meets quality standards, and should be downright dangerous.
“Many people are in desperate need of medication. And many say, 'Hey, I know how we can make money quickly.' That combination leads to unscrupulous activities,” Leonard said.
How to identify fake Wegovy or Ozempic
On August 10, Novo Nordisk said Reuters that even though it spent billions to spice up production, the shortages would last until 2024. So the corporate has a website to Help consumers tell the difference between FDA-approved and counterfeit products. (Both Leonard and Johnson said that pharmacies that make drugs themselves normally dispense their versions in a liquid vial and insulin syringe relatively than a pen, making it very difficult to calculate the proper dosage.)
For reference, real Ozempic pens:
- Do not extend or extend the dosage
- Currently available in three doses: 0.25/0.5 milligram pen, 1 milligram pen or 2 milligram pen
- Comes in a pack of 4 needles that attach on to the pen, apart from the 0.25/0.5 milligram dose, which comes with six needles
- Show only the intended actions when dialing from 0
The company also told consumers that while it has not yet discovered any Wegovy counterfeits within the U.S., they must be looking out for the next:
- Original Wegovy pens are fixed-dose auto-injectors and should not have a push button to manage the medication.
- There is not any choice to set a dose or extend the length of the pen. Instead, pens can be found in strengths of 0.25 milligrams, 0.5 milligrams, 1 milligram, 1.7 milligrams, and a pair of.4 milligrams.
The problem of counterfeiting is prone to worsen, which is a serious cause for concern, in keeping with the experts we interviewed.
Fitch didn't mince his words.
“The drug semaglutide crosses the blood-brain barrier and gets into the brain. If you get something from somewhere without anyone monitoring its production, it's scary,” she said.
Whether it's scary or not, knowledge alone isn't enough to discourage patients like Susan M. She said that despite the risks, she was willing to take the prospect when her current supply of one other drug ran out and her insurance company denied a claim to cover Wegovy.
“I used to be totally against compound interest. But now? Well, if that's my only option, then I'll do it because it's better than nothing,” she said.
If you see something, say something
The company asks consumers to buy their medications through authorized distributors and to examine the photos to make certain they're receiving the actual product and never a fake. To report suspected counterfeit semaglutide products, they need to call Novo Nordisk Customer Service at 800-727-6500 Monday through Friday from 8:30 a.m. to six:00 p.m. ET.
If you experience antagonistic reactions related to the usage of a possibly counterfeit product, discontinue use immediately and call your National Poison Control Center at 800-222-1222 and/or visit the national website.