August 22, 2023 – In horse racing, a ‘false favourite’ is a horse whose odds do not match its abilities, and which is unlikely to perform. The same goes for fake or counterfeit versions of the drug semaglutide, sold as Wegovy for weight loss and as Ozempic for type 2 diabetes, flooding North American and global markets.
The temptation is great, causing thousands to risk their health to find these products by any means necessary. Even some doctors get in on the shell game, even though the odds (and the safety) are stacked.
Over the past two years, the surge in interest and popularity has catapulted Wegovy from obesity clinics into the world of Hollywood stars and TikTok influencers. The result was a boon for Danish drugmaker Novo Nordisk, along with production problems due to limited supplies, shortages and a wave of counterfeits.
While Novo takes Nordisk legal action against medical spas, weight loss and wellness clinics, and even compounding pharmaciesCase reports document administration errors and accidental overdoses, calls to poison control hotlines, and visits to hospital emergency rooms.
For the millions of patients who depend on access to these medications, forewarned is truly on the fence; How do you recognize fake from real?
“We have received calls about several of these cases,” says Jimmy Leonard, PharmD,director of clinical services at the Maryland Poison Center at the University of Maryland School of Pharmacy in Baltimore. “There have been people who immediately gave themselves a tenfold overdose,” he said.
“Boy, were they sick?”
Amber Johnson, PharmD, director of the Utah Poison Control Center and assistant professor of pharmacy at the University of Utah in Salt Lake City, said, “We’ve had as many reports so far as in 2022,” also noting that most of them were calling about compound errors.
Compounded medications are not approved by the FDA, but may be produced during an official drug shortage. Ozempic and Wegovy are currently on the FDA’s shortage list, but the federal agency warned in May that it has received reports of people experiencing “side effects” after using compounded versions of the drugs.
Johnson, co-author of a semaglutide case series published at the end of Junesaid there were more than three times as many cases of accidental administration errors and adverse events related to semaglutide in 2022 than in 2021.
All told, poison control centers across the country are seeing more and more of these cases, which Johnson says is cause for concern.
“These errors have caused people to suffer long-term side effects, some of whom have ended up in the emergency department.” she said.
Compounding versus counterfeiting
In its May warning, the FDA said some products sold as semaglutide may not contain the same active ingredient as the FDA-approved version, but rather a salt form, which has not been shown to be safe or effective.
Novo Nordisk (who declined to speak to WebMD) followed up with its own statement a few weeks later: warn the public that a counterfeit formulation of Ozempic was circulating in the US. This version contained a long-acting form of insulin and led to a side effect. In both situations, the perpetrator was compounding pharmacies.
Compounding refers to creating a customized form of a drug to meet a specific need (for example, removing something a patient may be allergic to, such as lactose or a dye).
Because compounded drugs do not require FDA review, they can pose certain risks, especially when the compounded drug pharmacist does not have access to the actual FDA-approved component, which in this case is a proprietary chain of amino acids or proteins that pass through the bloodstream. brain barrier. This unique feature is a key reason why Wegovy works so well for chronic weight management: it targets a part of the brain that regulates appetite. It is also a major reason why it is in such high demand.
Susan M., a 45-year-old journalist from Texas who gained 100 pounds after the birth of her second child, explained that using Wegovy helped her personally accept and understand the obesity disease process in ways she hadn’t before. .
“It wasn’t until I took that drug that I thought about it the same way I would think about taking a drug for blood sugar or an antihypertensive for blood pressure or something like that,” she said. “What amazed me was the absence of ‘food noise,’ as if food is always on the edge of your thoughts,” she said.
Experts in the field of obesity medicine agree on the drug’s unique properties and effectiveness.
“With older medications, only about 10% of people could achieve a 20% weight loss. With semaglutide, 40% of people can now get into that 20% weight loss category, which is why it’s in such high demand,” says Angela Fitch, MD, chief medical officer of healthcare company Knownwell and president of the Association for Obesity Medicine.
But Fitch also pointed out that “every compounded product today is counterfeit. The basic source does not come from companies that are legally allowed to make it, and there is no control over it. It’s like [the television show] Break bad,” she said.
Please note that compounding products is not illegal; the process is permitted – especially during drug shortages – as long as certain quality controls and other requirements in the Federal Food, Drug, and Cosmetic Act are met. Currently, Novo Nordisk is the only company in the US holding the patents for Ozempic and Wegovy, and no FDA-approved generic versions of semaglutide exist. That means that Ozempic or Wegovy, obtained from a compounding pharmacy, medical spa, or online, is not the genuine article, has not been thoroughly reviewed or meets quality standards, and may be downright dangerous.
“There are many people who are desperate for medicine. And there are a lot of people who say, “Hey, I know how we can make money fast.” That combination leads to unscrupulous activities,” Leonard said.
How to recognize fake Wegovy or Ozempic
On August 10, Novo Nordisk told Reuters that even though it spent billions to boost production, shortages would continue into 2024. That’s what the company did a website to Help consumers tell the difference between FDA-approved products and counterfeit products. (Both Leonard and Johnson said compounding pharmacies typically dispense their versions in a liquid vial and insulin syringe rather than a pen, which makes calculating the correct dosage very difficult.)
For reference, real Ozempic pens:
- Do not extend or increase in length when adjusting the dose
- Are currently available in three doses: 0.25/0.5 milligram pen, 1 milligram pen or 2 milligram pen
- Comes in a box with four needles that attach directly to the pen, except the 0.25/0.5 milligram dose, which comes with six needles
- Tone only intended when dialing in from 0
The company also told consumers that while no Wegovy counterfeits have yet been discovered in the U.S., consumers should be aware of the following:
- Genuine Wegovy pens come as fixed-dose auto-injectors and do not have a push button to deliver the medication.
- There is no option to set a dose or increase the length of the pen. Instead, pens are available in 0.25 milligram, 0.5 milligram, 1 milligram, 1.7 milligram and 2.4 milligram.
The counterfeiting problem is expected to worsen, which was a major cause for concern according to all the experts we spoke to.
Fitch didn’t mince his words.
“This drug semaglutide is a drug that crosses the blood-brain barrier; it ends up in your brain. When you take something from somewhere unattended, without anyone monitoring production, it’s scary,” she says.
Scary or not, knowledge isn’t enough to distract patients like Susan M., who said despite the risks, she was willing to take a chance when her current supply of another drug ran out and her insurance company denied a request to cover Wegovy.
“I used to be absolutely against compounding. 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 purchase their medications through authorized distributors and view the photos to ensure 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, 8:30 AM to 6:00 PM ET.
If you have any adverse reactions related to using a possible counterfeit product, stop immediately and contact National Poison Control at 800-222-1222 and/or visit national website.