Aug. 22, 2023 – In horse racing, a “false favorite” is a horse whose odds don’t reflect its abilities, and who’s unlikely to deliver. The same is true of fake or counterfeit versions of the drug semaglutide, sold as Wegovy for weight loss and as Ozempic for type 2 diabetes, which are flooding North American and global marketplaces.
The temptation is great, leading thousands to risk their health to find these products by any means possible. Even some doctors are getting into the shell game, even though the odds (and safety) are stacked.
Over the past 2 years, the surge in interest and popularity catapulted Wegovy from obesity clinics to the world of Hollywood stars and TikTok influencers. The result has been a boon for Danish drugmaker Novo Nordisk, along with production headaches linked to limited supplies, shortages, and a surge in counterfeits.
While Novo Nordisk takes legal action against medical spas, weight loss and wellness clinics, and even compounding pharmacies, case reports describe administration errors and unintentional overdoses, calls to poison control center hotlines, and visits to hospital emergency rooms.
For millions of patients who rely on access to these medications, forewarned is truly forearmed; how do you know a fake from the real deal?
“We’ve gotten calls about several of these cases,” said Jimmy Leonard, PharmD,director of clinical services at the Maryland Poison Center at the University of Maryland School of Pharmacy in Baltimore. “We’ve had people give themselves tenfold overdoses right off the bat,” he said.
“Boy, 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 “we’ve actually had as many reports up to this point as we had in 2022,” also noting that most were calls about compounding errors.
Compounded medicines are not FDA-approved but are allowed to be made 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 having “adverse events” after using compounded versions of the drugs.
Johnson, co-author of a semaglutide case series published in late June, said that in 2022, there were more than three times as many cases of accidental administration errors and adverse events related to semaglutide than in 2021.
All told, poison control centers across the country are seeing more and more of these cases, which Johnson said is a cause for concern.
“With these errors, people are having prolonged side effects that have landed a few of them in the emergency department.” she said.
Compounding vs. Counterfeit
In its warning in May, the FDA said some products being sold as semaglutide might not contain the same active ingredient as the FDA-approved version but rather a salt form, which have not been shown to be either safe or effective.
Novo Nordisk (which declined to speak with WebMD) followed with its own statement a few weeks later, alerting the public that a counterfeit formulation of Ozempic was circulating in the U.S. This version contained a long-acting form of insulin and led to an adverse reaction. In both situations, the culprit was compounding pharmacies.
Compounding refers to making a custom form of a medication to meet a specific need (for example, removing something that a patient might be allergic to, such as lactose or a dye).
Because compounded drugs do not require FDA review, they may carry certain risks, especially when the compound pharmacist does not have access to the actual FDA-approved component, which in this case is a patented chain of amino acids or proteins that cross the blood-brain barrier. This unique attribute is an important reason why Wegovy works so well for chronic weight management – it targets a part of the brain that regulates appetite. It is also an important 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 ways that she had not before.
“It wasn’t until I took that drug that I thought of it the same way that I might think of taking a drug for blood sugar or an antihypertensive for blood pressure or something like that,” she said. “The thing that blew my mind was the absence of ‘food noise,’ like food is always on the edge of your thoughts,” she said.
Obesity medicine experts agree on the drug’s unique qualities and effectiveness.
“With older medications, only about 10% of people were able to achieve a 20% weight loss. With semaglutide, 40% of people are now able to get into that 20% weight loss category, which is why there’s so much demand for it,” said Angela Fitch, MD, chief medical officer of health care company Knownwell, and president of the Obesity Medicine Association.
But Fitch also pointed out that “any compounded product today is counterfeit. The base source isn’t coming from companies that are legally allowed to make it, and there’s no control over it. It’s like [the television show] Breaking Bad,” she said.
Mind you, compounding products is not illegal; the process is allowed – especially during drug shortages – so long as certain quality control and other requirements in the Federal Food, Drug, and Cosmetic Act are met. Currently, Novo Nordisk is the only company in the U.S. with 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, a medical spa, or online is not the genuine article, has not had a thorough review or met quality standards, and might be downright dangerous.
“There are a lot of people desperate for medications. And there are a lot of people that say, ‘Hey, I know how we can make a quick buck.’ That combination leads to some unscrupulous activities,” said Leonard.
How to Spot Fake Wegovy or Ozempic
On Aug. 10, Novo Nordisk told Reuters that although it was spending billions to boost output, shortages would last into 2024. So the company has a website to help consumers tell the difference between FDA-approved and counterfeit products. (Both Leonard and Johnson said that compounding pharmacies are mostly dispensing their versions in a liquid vial and an insulin syringe rather than a pen, which make calculating proper dosage very difficult.)
For reference, genuine Ozempic pens:
- Do not extend or increase in length when setting the dose
- Are currently available in three doses: 0.25/0.5-milligram pen, 1-milligram pen, or 2-milligram pen
- Come in a box that includes four needles that directly attach to the pen, except the 0.25/0.5-milligram dose, which comes with six needles
- Only show intended does when dialed up from 0
The company has also told consumers that although it’s not yet discovered Wegovy counterfeits in the U.S., consumers should look out for the following:
- Genuine Wegovy pens come as fixed-dose auto-injectors, and do not have a push button to administer the medication.
- There is no option to set a dose or increase the length of the pen. Rather, pens are available in 0.25 milligram, 0.5 milligram, 1 milligram, 1.7 milligrams, and 2.4 milligrams.
The counterfeit problem is expected to worsen, which all of the experts we spoke to said was a great cause for concern.
Fitch did not mince words.
“This drug semaglutide is a drug that crosses the blood-brain barrier; it goes into your brain. If you are getting something from somewhere without oversight, without someone monitoring production, that’s scary,” she said.
Scary or not, knowledge is not enough to detract patients like Susan M., who said that despite the risks, she was willing to take a chance when her current supply of another medication had run out and if her insurance company turned down a request to cover Wegovy.
“Before, I was dead set 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 is asking consumers to purchase their medications through authorized distributors, and review the photographs to ensure they are receiving the real product and not a fake. To report suspected counterfeit semaglutide products, they should call Novo Nordisk customer care at 800-727-6500 Monday-Friday, 8:30 a.m. to 6 p.m. ET.
If you have any side effects related to use of a possibly counterfeit product, stop right away and contact national Poison Control at 800-222-1222 and/or visit the national website.
Nguồn bài viết : https://www.webmd.com/obesity/news/20230822/fake-ozempic-wegovy-stay-safe?src=RSS_PUBLIC