August 22, 2023 – In the world of horse racing, a “false favorite” refers to a horse whose odds do not accurately reflect its abilities and is unlikely to perform well. Similarly, there is a surge of fake or counterfeit versions of the drugs semaglutide, sold as Wegovy for weight loss and Ozempic for type 2 diabetes, flooding the North American and global markets. This has led thousands of people to take illegal risks in order to obtain these products. Shockingly, even some doctors are participating in this dangerous game, despite the high risks involved.
Over the past two years, Wegovy has gained immense popularity and fame, extending beyond obesity clinics to the realm of Hollywood stars and TikTok influencers. This has resulted in tremendous profits for Danish drugmaker Novo Nordisk. However, it has also led to production issues, limited supplies, shortages, and an increase in counterfeit drugs. Novo Nordisk is taking legal action against medical spas, wellness and weight loss clinics, and compounding pharmacies that are involved in this illicit trade. There have been numerous reports of unintentional administration errors, overdoses, calls to poison control centers, and visits to emergency rooms. This poses a significant threat to the millions of patients who rely on these drugs. Therefore, it is crucial to be able to identify fake drugs from authentic ones.
Several case reports have revealed the severity of the issue. Jimmy Leonard, PharmD, the director of clinical services for the Maryland Poison Center, stated that they have received calls regarding multiple cases where individuals have overdosed by ten times the recommended dose. Amber Johnson, PharmD, the director of the Utah Poison Control Center, noted that they have had a similar number of reports on compound errors compared to the previous year. Compounded drugs are not approved by the FDA, but they are manufactured during official drug shortages. However, the FDA has received reports of adverse events linked to compound versions of semaglutide.
The counterfeit drugs sold as semaglutide may not contain the active ingredient found in the FDA-approved version, but rather a potentially unsafe form of salt. Novo Nordisk issued a statement warning the public about a counterfeit formulation of Ozempic circulating in the US, which caused adverse reactions. Compounding pharmacies have been identified as the source of these counterfeit drugs. Compounded drugs carry certain risks since they do not undergo FDA review. Novo Nordisk holds the patents for Ozempic and Wegovy in the US, and there are no FDA-approved generic versions of semaglutide. Therefore, drugs obtained from compounding pharmacies, medical spas, or online sources are not genuine, have not undergone proper review, and may be extremely dangerous.
Identifying fake Wegovy or Ozempic is crucial. Novo Nordisk has provided information on their website to help consumers differentiate between FDA-approved products and counterfeits. Genuine Ozempic pens have specific characteristics, such as no extension or increase in length when adjusting the dose, availability in multiple strengths, and the inclusion of needles in the packaging. Genuine Wegovy pens, on the other hand, come as fixed-dose auto-injectors without a button to deliver the medication. These pens are available in specific doses, and there is no option to set or increase the dosage. It is important to be aware that the counterfeiting problem is expected to worsen.
Obesity medicine experts highlight the risks associated with counterfeit drugs and emphasize the need for caution. Angela Fitch, MD, chief medical officer for healthcare company Knownwell and president of the Obesity Medicine Association, compares the use of compound products to the television show “Breaking Bad,” stating that any compounded product is considered counterfeit. Fitch warns about the lack of control and supervision in the production of compounded drugs, especially since semaglutide is a drug that crosses the blood-brain barrier and affects the brain. Despite the risks, there are patients who are desperate for medication and are willing to take the risk of using counterfeit drugs when their supply runs out or when insurance coverage is denied.
Novo Nordisk encourages consumers to purchase their drugs from authorized distributors and provides resources for consumers to verify the authenticity of their products. They also urge individuals to report suspected counterfeit semaglutide products to their customer service line and to seek immediate medical attention if they experience any side effects. It is crucial for the public to stay informed and vigilant in order to protect their health and well-being.
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August 22, 2023 – In horse racing, a “false favorite” is a horse whose odds do not reflect his abilities and who is unlikely to deliver. The same is true of fake or counterfeit versions of the drug semaglutide, sold as Wegovy for weight loss and Ozempic for type 2 diabetes, which are flooding North American and global markets.
The temptation is great and leads thousands of people to risk their health to get these products by any means possible. Even some doctors are getting into the trenches game, despite the odds (and certainties) being high.
Over the past two years, increased interest and popularity has 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, along with production problems related to limited supplies, shortages and an increase in counterfeits.
While Novo Nordisk takes legal action against medical spas, wellness and weight loss clinics, and even compounding pharmaciescase reports describe unintentional administration errors and overdoses, calls to poison control center hotlines, and visits to hospital emergency rooms.
For millions of patients who depend on access to these drugs, forewarning is forewarning indeed; How to tell a fake from a real one?
“We’ve had calls about a number of these cases,” said Jimmy Leonard, PharmD,director of clinical services for the Maryland Poison Center at the University of Maryland School of Pharmacy in Baltimore. “We’ve had people overdose ten times over from the start,” he said.
“Wow, were they sick?”
Amber Johnson, PharmD, director of the Utah Poison Control Center and an assistant professor of pharmacy at the University of Utah in Salt Lake City, said that “actually, we’ve had as many reports up to now as we have in 2022,” also noting that most were calls on compound errors.
Compound drugs are not FDA-approved, but are allowed to be manufactured during an official drug shortage. Ozempic and Wegovy are currently on the FDA’s shortage list, but the federal agency warned in May that he received reports of people having “adverse events” after using compounded versions of the drugs.
Johnson, co-author of a semaglutide case series posted end of junesaid that in 2022, there were more than three times as many cases of accidental dosing errors and adverse events related to semaglutide than in 2021.
All told, poison control centers across the country are seeing more and more cases of this type, which Johnson says is cause for concern.
“With these bugs, people have prolonged side effects that have landed some of them in the emergency department.” she said.
Composition vs. Counterfeiting
In its May warning, the FDA said that some products sold as semaglutide might not contain the same active ingredient as the FDA-approved version, but rather a form of salt, which has not been shown to be safe or effective.
Novo Nordisk (which declined to speak to WebMD) followed up with its own statement a few weeks later, alerting the public that a counterfeit formulation of Ozempic was circulating in the US. This version contained a long-acting form of insulin and caused an adverse reaction. In both situations, the culprit was compounding pharmacies.
Compounding refers to making a custom form of a drug to meet a specific need (for example, eliminating something a patient might be allergic to, like lactose or a dye).
Because compounded drugs do not require FDA review, they can carry certain risks, especially when the compounding pharmacist does not have access to the actual FDA-approved compound, which in this case is a proprietary chain of amino acids or proteins that crosses the blood. brain barrier. This unique attribute is a big 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 taking Wegovy helped her personally accept and understand the disease process of obesity in a way she hadn’t before. before.
“It wasn’t until I took that medication that I thought about it in the same way that you might think about taking a blood sugar drug or a blood pressure antihypertensive or something like that,” he said. “What struck me was the absence of ‘food noise,’ as if food was always on the edge of your thoughts,” she said.
Obesity medicine experts agree on the drug’s unique qualities and efficacy.
“With the older drugs, only about 10% of people were able to achieve a 20% weight loss. With semaglutide, 40% of people can now fall into that 20% weight loss category, which is why there’s such a demand,” said Angela Fitch, MD, chief medical officer for health care company Knownwell and president of Obesity Medicine Association.
But Fitch also noted that “any composite product today is a counterfeit. The base source does not come from companies that are legally authorized to produce it and there is no control over it. It is like [the television show] breaking bad,” she said.
Of course, mixing products is not illegal; the process is permitted, especially during drug shortages, as long as certain quality controls and other requirements of the Federal Food, Drug, and Cosmetic Act are met. Currently, Novo Nordisk is the only company in the US with the Ozempic and Wegovy patents, and there are no FDA-approved generic versions of semaglutide. That means Ozempic or Wegovy obtained from a compounding pharmacy, medical spa, or online are not genuine items, have not been thoroughly reviewed or met quality standards, and could be downright dangerous.
“There are many people desperate for medicine. And there are a lot of people who say, ‘Hey, I know how we can make a quick buck.’ That combination leads to some unscrupulous activities,” Leonard said.
How to spot fake Wegovy or Ozempic
On August 10, Novo Nordisk told Reuters that even though it was spending billions to ramp up production, the shortage would last until 2024. So the company has a websiteo Help consumers differentiate between FDA-approved products and counterfeit products. (Both Leonard and Johnson said most compounding pharmacies dispense their versions in a liquid vial and insulin syringe rather than a pen, making calculating the proper dose very difficult.)
For reference, genuine Ozempic pens:
- Do not extend or increase the length when adjusting the dose.
- They are currently available in three strengths: 0.25/0.5 milligram pen, 1 milligram pen, or 2 milligram pen.
- They come in a box that includes four needles that attach directly to the pen, except for the 0.25/0.5 milligram dose, which comes with six needles.
- The expected is only shown when dialed from 0
The company has also told consumers that while counterfeit Wegovy has yet to be discovered in the US, consumers should be aware of the following:
- Genuine Wegovy pens come as fixed-dose auto-injectors and do not have a button to deliver the medication.
- There is no option to set a dosage or increase the length of the pen. Rather, the pens are available in 0.25 milligrams, 0.5 milligrams, 1 milligrams, 1.7 milligrams, and 2.4 milligrams.
The counterfeiting problem is expected to worsen, which was said by all the experts we spoke to to be of great concern.
Fitch did not mince words.
“This drug semaglutide is a drug that crosses the blood-brain barrier; enter your brain If you get something from somewhere without supervision, without someone controlling the production, it’s scary,” he said.
Frightening or not, knowledge isn’t enough to detract from patients like Susan M., who said that despite the risks, she was willing to take the risk when her current supply of another drug ran out and if her insurance company turned down the risk. an application to cover Wegovy.
“Before, I was totally against capitalization. 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 drugs through authorized distributors and review the photos to make sure they are getting the real thing 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 pm EST.
If you experience any side effects related to the use of a possibly counterfeit product, stop immediately and contact National Poison Control at 800-222-1222 and/or visit the national website.
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