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Counterfeit versions of weight-loss related medications are “detrimental to the field of obesity medicine” and can pose severe risks to patient health, particularly to those who rely on them most, according to medical experts.
There is growing concern that the shortage of these popular weight-loss related drugs has created a market for suspected counterfeits.
The World Health Organization (WHO) warned Monday that global shortages of drugs that are indicated to manage type 2 diabetes and, in some cases, approved for weight loss, also known as glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, “have been associated with an increase in reports of falsified GLP-1-RA” over the past year.
Drugs that fall under this category include Novo Nordisk’s Wegovy and Ozempic.
On Wednesday, Novo said that it is steadily increasing its capacity to produce more of its weight-loss drug Wegovy than ever before. However, the company still cautioned that “overall demand will continue to exceed supply, which means that some patients may still have difficulty filling Wegovy prescriptions.”
For Ozempic, all doses are currently available as indicated on the Food and Drug Administration (FDA) Drug Shortage website, though the company noted that it “cannot control which specific pharmacies or patients receive Ozempic.”
“We continue to build and invest in new manufacturing capacity,” Novo said. In 2024, it plans to invest approximately $6.5 billion in production, compared to investments of approximately $3.6 billion last year.
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Representatives for Eli Lilly have not responded to FOX Business’ request for comment.
“Shortages adversely impact access to medical products and create a vacuum which is often filled by falsified versions,” according to WHO, which noted that these shortages are “likely to have disproportionate consequences” on diabetes type II patients.”
These fake versions are often sold through unregulated channels like social media platforms, the agency said.
Counterfeit versions of the drugs semaglutide and tirzepatide, which are sold under the brand names Wegovy, Ozempic, Mounjaro and Zepbound “are detrimental to the field of obesity medicine overall,” Dr. Daniel Maselli, an endobariatric physician and research associate director of True You Weight Loss in Atlanta, told FOX Business.
“The emergence of counterfeit agents doesn’t just pollute the chemical makeup of these medications, it also pollutes the public’s ability to trust anti-obesity medications period,” Maselli said. “At that point, a healthy skepticism of a novel medication becomes an outright distrust, which puts up even more barriers for patients with obesity to have access to safe and effective treatments.”
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While this can result in great mistrust in novel medications, Dr. Jamie Mullally, an endocrinologist at Westchester Medical Center Health Network in Westchester County, New York, stressed that there are other concerns.
For one, these fake versions are compounded medications, which are not regulated by federal health officials.
“I think the main issue is a lack of regulation by the FDA,” Mullally said. “We don’t know if they’re effective or if they are safe.”
Companies such as Novo and Eli Lilly, which manufactures Mounjaro and Zepbound, “go through years and years of safety trials and effectiveness trials and these compounding versions of medicine are inherently different.”
“You just don’t know what’s in there because nobody’s regulating them,” Mullally, who has a specialty in obesity medicine, added.
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The FDA has issued warnings about compounded drug products containing semaglutide or semaglutide salts.
In an October 2023 letter to the National Association of Boards of Pharmacy, the FDA stressed that “compounded drugs, including compounded semaglutide drug products, are not FDA-approved and do not receive premarketing review for safety, efficacy, and quality.”
Just weeks after that letter was issued, Novo even announced it was taking legal action against certain pharmacies for allegedly selling drugs claiming to contain semgaglutide that are not approved by the FDA.
Jason Brett, executive director of Medical Affairs at Novo Nordisk Inc. said that several tests of the compounded drugs that claimed to contain semaglutide showed “concerning levels of unknown impurities.” One sample in particular had a concerning level of 33%, which may pose potential safety risks to patients, according to Novo.
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With weight-loss drugs in general, Mullally noted that doctors have been worried about cardiac side effects.
With these fake versions, there are even more concerns regarding whether the drug is even sterile.
“There may be mishandling of the drug itself that could lead to an infection,” she said.
If the dose is too high, that is also a worry because it can cause symptoms ranging from severe nausea, vomiting to pancreatitis, she said, though she noted that’s just speculation, given that she isn’t aware of the drugs that are being mixed together.
Similarly, WHO also stressed concerns that these false medications can “cause toxic reactions.”
“They are neither approved nor controlled by competent authorities and may have been produced in unhygienic conditions by unqualified personnel, contain unknow impurities and can be contaminated with bacteria,” WHO said.