As counterfeit ozempics circulated within the US, the Food and Drug Administration has warned Americans.
In an announcement on April 14, the FDA stated Novo Nordisk, producer of Ozempic and Wegovy, had knowledgeable the company that “1 mg of a whole lot of items of counterfeit ozempic (semaglutide) injection” is within the US drug provide chain.
Ozempic is an injectable agent accredited for the remedy of sort 2 diabetes. The similar drug, however greater dose, Wegovy, is accredited to deal with weight problems.
Cheap Ozempic imitations are rising in recognition, however are they secure?
According to the FDA, medicines utilizing lot quantity PAR0362 and serial numbers beginning with the primary 8 digits 51746517 shouldn’t be used, offered or distributed. (Food and Drug Administration)
The FDA advises sufferers, wholesalers, retail pharmacies and healthcare professionals to take a look at the Ozempic merchandise they personal.
Drugs labeled with lot quantity PAR0362 shouldn’t be used, offered or distributed per agent utilizing serial numbers beginning with the primary 8 digits 51746517.
“The FDA is conscious of six adversarial occasion stories associated to this lot, however none of them seems to be associated to counterfeit merchandise,” the assertion stated. “All six adversarial occasions have been reported by Novo Nordisk.”
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“At Novo Nordisk, affected person security is our primary precedence and we take the rise in circumstances that embrace counterfeit variations of Ozempic very significantly,” he stated.
The FDA advises sufferers, wholesalers, retail pharmacies and healthcare professionals to take a look at the Ozempic merchandise they personal. (istock)
“That’s a priority and we’ll do every thing we will to warn sufferers, well being professionals, wholesalers and retail pharmacies when counterfeiting circumstances come up.”
The seized merchandise are at the moment being examined by the FDA and Novo Nordisk to find out the id, high quality, or security of the drug.
The FDA investigation is ongoing, the company added.
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Dr. Brett Osborne, a Florida neurosurgeon and longevity physician, prescribed semaglutide medication to his sufferers, however beforehand spoke in regards to the risks of low-cost, counterfeit variations.
“You ought to solely use drug grade variations prescribed by licensed physicians.”
“These imitations are inherently in danger as a result of they’re synthesized in a non-health atmosphere the place there isn’t any required high quality assurance or high quality management.”
These medication could be dangerous within the absence of monitoring sources or manufacturing high quality, Osborne warned.
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“When you are made in an unregulated atmosphere, you do not know what you are placing in your physique.”
Drugs like Ozempic require “manufacturing accuracy” in response to Osborn.
Ozempic is an injectable agent accredited for the remedy of sort 2 diabetes. The similar drug, however greater dose, Wegovy, is accredited to deal with weight problems. (Getty Images)
“You ought to solely use a drug grade model prescribed by a licensed doctor,” he stated.
“The dangers for these variants are too excessive and there aren’t any laws to make sure that they’re correctly created.”
Doctors must be cautious when ordering remedy on-line.
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The seized merchandise are at the moment being examined by the FDA and Novo Nordisk to find out the id, high quality, or security of the drug. (istock)
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“When used accurately, these medication are highly effective instruments, however could be harmful with the incorrect arms,” he stated.
“Always seek the advice of along with your healthcare supplier about correct coaching and expertise when utilizing these medicines. Safety.”