As costs for Ozempic have risen in current months, many individuals could also be in search of cheaper options for managing diabetes or weight reduction.
Some docs, together with the U.S. Meals and Drug Administration (FDA), are warning of the potential dangers of utilizing “knock-off manufacturers” of semaglutides, which belong to the GLP-1 class of medicines.
Dr. Brett Osborn, a Florida neurosurgeon and longevity physician who has prescribed pharmaceutical-grade variations of those medicines since 2019, mentioned he’s “involved” by this development.
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“Attributable to the price of brand-name Ozempic, increasingly persons are turning to cheaper knock-off variations, typically discovered on-line or by non-regulated channels,” he instructed Fox Information Digital.
As costs for Ozempic have risen in current months, many individuals could also be in search of cheaper options for managing diabetes or weight reduction. (REUTERS/Hollie Adams/File Photograph)
“These knock-offs are synthesized in non-medical environments with out the mandatory high quality assurance or high quality management, making them inherently dangerous.”
There’s the potential for these medicines to be dangerous when there’s no oversight of their supply or manufacturing high quality, Osborn warned.
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“After they’re made in unregulated environments, there isn’t any telling what you’re placing into your physique.”
Dr. Sue Decotiis, MD, a weight-loss physician in New York Metropolis, confirmed that some persons are in search of low-cost options, however famous that their potential risks have gotten extra extensively identified.
“This occurred to considered one of my sufferers earlier than he got here to me,” she shared with Fox Information Digital.
There’s the potential for these medicines to be dangerous when there’s no oversight of their supply or manufacturing high quality, a physician warned. (iStock)
“He received a medicine from a pharmacy in Florida after which the drug simply stopped working. Weeks later, the pharmacy shut down.”
Lots of the illegitimate pharmacies that aren’t credited by their state’s native pharmacy board will “simply disappear,” Decotiis mentioned.
“It’s best to solely be utilizing pharmaceutical-grade variations prescribed by a licensed physician.”
The most important threat is that the affected person has no concept what’s within the medicines, she warned, as disreputable suppliers may add fillers to the merchandise.
Think about the supply
Medicines like Ozempic require “precision in manufacturing,” in accordance with Osborn.
“It’s best to solely be utilizing pharmaceutical-grade variations prescribed by a licensed physician,” he mentioned.
“The chance with these variants is simply too excessive, and there’s no regulation to make sure they’re made correctly.”
Whereas some on-line platforms could also be authorized as a result of a well being care supplier is writing the prescription, there may very well be different related dangers, a physician warned. (iStock)
Individuals ought to use warning when ordering any medicine on-line, docs agree.
“Except you’re getting the medicine from a licensed pharmacy with a sound prescription from a physician, buying Ozempic or its knockoffs on-line is harmful,” Osborn warned. “You may’t confirm the product’s supply, elements or security.”
“I do know of a number of nurse practitioners who stockpile Ozempic knock-offs and promote them on their Fb pages,” he famous. “In essence, there’s a large black marketplace for it.”
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Whereas some on-line platforms could also be authorized as a result of a well being care supplier is writing the prescription, there may very well be different related dangers, Decotiis famous.
“It could be that there isn’t any customized care or any physique composition being adopted.”
Shortages of those unregulated medicines are additionally frequent.
“That is problematic after paying upfront, as many sufferers by no means get the medicine they thought they’d get,” Decotiis mentioned. “The customer should be conscious.”
One of many greatest crimson flags is that if an internet platform provides to straight ship a medicine, Decotiis famous.
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“If you should purchase it straight, it’s an illegal web site,” she famous. “These websites get shut down every day — who is aware of what they’re really dishing out.”
Reliable compound firms solely work with physicians, Decotiis mentioned, and don’t talk straight with sufferers.
Value-saving choices
If value is a priority, there are safer options than buying knock-off manufacturers, consultants say.
“Many pharmaceutical firms provide affected person help packages — your physician can information you to these choices,” Osborn mentioned.
“There are different prescription medicines that could be extra inexpensive, however nonetheless secure and efficient for reducing insulin ranges and driving weight reduction,” he added, a physician mentioned. (iStock)
“There are different prescription medicines that could be extra inexpensive, however nonetheless secure and efficient for reducing insulin ranges and driving weight reduction,” he added.
One instance is metformin, one other time-tested diabetes medicine.
Added Osborn, “Not at all must you flip to unregulated options simply to economize.”
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Decotiis acknowledged that it may be “very tough” for many individuals to acquire Ozempic and comparable medicines.
“These medicine are costly, and it’s onerous for many individuals to get the care they want,” she mentioned.
“Not at all must you flip to unregulated options simply to economize.”
“For compounded merchandise, you’re paying by ounce, whereas with large pharma, you’re paying for a month-to-month provide,” she went on.
“With the massive pharma medicine, you’re paying extra up entrance, however because it goes up in dose, it’s really cheaper.”
Medicines like Ozempic ought to solely be prescribed by a doctor licensed to put in writing prescription, docs advise. (iStock)
With compounded medicines, a licensed pharmacist or doctor combines, mixes or alters the elements to create a custom-made drug to satisfy a affected person’s particular person wants, however it’s not FDA-approved, in accordance with the company.
“This implies the company doesn’t evaluation compounded medicine for security, effectiveness or high quality earlier than they’re marketed,” the FDA states on its web site.
‘Security first’
Osborn reiterated that medicines like Ozempic ought to solely be prescribed by a doctor licensed to put in writing prescriptions — “not a nurse practitioner by way of a telemedicine go to or a chiropractor.”
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“When used accurately, these medicines are highly effective instruments, however will be harmful within the fallacious fingers,” he mentioned.
“At all times seek the advice of a well being care supplier with the right coaching and expertise in utilizing these medicines. Security first.”
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The FDA and the World Well being Group (WHO) have each investigated instances of counterfeit Ozempic merchandise in current months and years.
The FDA recommends that retail pharmacies solely buy genuine Ozempic by licensed distributors of Novo Nordisk, the corporate that makes Ozempic and Wegovy, and that sufferers solely get hold of Ozempic with a sound prescription by state-licensed pharmacies. (iStock)
“FDA is conscious that some sufferers and well being care professionals might look to unapproved variations of GLP-1 (glucagon-like peptide-1 receptor agonists) medicine, together with semaglutide and tirzepatide, as an possibility for weight reduction,” the company wrote in a current announcement on its web site.
“This may be dangerous for sufferers, as unapproved variations don’t bear FDA’s evaluation for security, effectiveness and high quality earlier than they’re marketed.”
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The FDA recommends that retail pharmacies solely buy genuine Ozempic by licensed distributors of Novo Nordisk, the corporate that makes Ozempic and Wegovy, and that sufferers solely get hold of Ozempic with a sound prescription by state-licensed pharmacies.
Fox Information Digital reached out to Novo Nordisk and the FDA for remark.
