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 hundreds risk their health to get these products by any means vital. Even some doctors are involved within the shell game, although the possibilities (and safety) are excellent.
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 attributable to 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 upon 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 almost all Calls attributable to cumulative errors.
Compounded drugs are usually not 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 opposed 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 lively ingredient because the FDA-approved version, but moderately a salt form whose safety or effectiveness has not been established.
Novo Nordisk (which declined to talk to WebMD) followed just a few 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, comparable to 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 an enormous reason why Wegovy works so well for chronic weight reduction—it targets a component of the brain that regulates appetite. It's also an enormous 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 sphere 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 doesn’t come from firms which are legally allowed to fabricate it and there is no such thing as a control over it. It is like [the television show] breaking Bad,” She said.
Mind you, compounding is not illegal; the process is permitted – especially during drug shortages – as long as certain quality control and other requirements of the Federal Food, Drug and Cosmetic Act are met. Currently, Novo Nordisk is the only company in the U.S. that holds the patents for Ozempic and Wegovy, and there are no FDA-approved generic versions of semaglutide. This means that any Ozempic or Wegovy you get at a compounding pharmacy, medical spa, or online is not the original, has not been thoroughly tested or meets quality standards, and may be downright dangerous.
“Many individuals are in desperate need of medication. And many say, 'Hey, I understand how we will generate profits quickly.' That combination results in 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 usually dispense their versions in a liquid vial and insulin syringe rather than a pen, making it very difficult to calculate the correct dosage.)
For reference, real Ozempic pens:
- Do not extend or prolong 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 four needles that attach directly to the pen, except for 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 in the U.S., they should be on the lookout for the following:
- Original Wegovy pens are fixed-dose auto-injectors and do not have a push button to administer the medication.
- There is no option to set a dose or extend the length of the pen. Instead, pens are available in strengths of 0.25 milligrams, 0.5 milligrams, 1 milligram, 1.7 milligrams, and 2.4 milligrams.
The problem of counterfeiting is likely to worsen, which is a major cause for concern, according to the experts we spoke to.
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 deter patients like Susan M. She said that despite the risks, she was willing to take the chance when her current supply of another drug ran out and her insurance company denied a claim to cover Wegovy.
“I was totally against compound interest. But now? Well, if that's my only option, then I'll do it since it's higher than nothing,” she said.
If you see something, say something
The company asks consumers to purchase their medications through authorized distributors and to check the photos to make sure they are receiving the real product and not a fake. To report suspected counterfeit semaglutide products, they should call Novo Nordisk Customer Service at 800-727-6500 Monday through Friday from 8:30 a.m. to 6:00 p.m. ET.
If you experience adverse reactions associated with the use of a possibly counterfeit product, discontinue use immediately and contact your National Poison Control Center at 800-222-1222 and/or visit the national website.