TOPIC: FDA Warns Consumers Not to Use Counterfeit Ozempic (semaglutide) Found in U.S. Drug Supply Chain
AUDIENCE: Consumer, Patient, Health Professional, Pharmacy, Endocrinology
ISSUE: FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. FDA and Novo Nordisk (manufacturer of Ozempic (semaglutide)) are testing the seized products and do not yet have information about the drugs’ identity, quality or safety.
Additionally, analysis found the needles from the samples are counterfeit. Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products. Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton.
FDA takes reports of possible counterfeit products seriously and works closely with other federal agencies and the private sector to help protect the nation’s drug supply. FDA’s investigation is ongoing, and the agency is working with Novo Nordisk to identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the U.S.
FDA is aware of five adverse events from this lot, none of which are serious and are consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain and constipation.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND:
Ozempic (semaglutide) is indicated:
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as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
RECOMMENDATIONS:
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FDA advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057. Some counterfeit products may still be available for purchase.
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FDA recommends retail pharmacies only purchase authentic Ozempic through authorized distributors of Novo Nordisk and review the photographs and information to confirm the legitimacy of their shipments.
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Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting.
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Entities, including online sellers, selling counterfeit and/or tampered medicines should be reported to FDA. Suspected counterfeit products may be reported to FDA by calling your local FDA consumer complaint coordinator or by reporting it directly at report suspected criminal activity.
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Retailers and patients may also contact Novo Nordisk customer care at 1-800-727-6500 with questions or concerns.
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