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Safety Report: Semaglutide medications Marketed for Type 2 Diabetes or Weight Loss - Warning and risks, USA

6 months ago source fda.gov

Outbreak

United States

WARNING
On December 21, 2023, the FDA published a warning to consumers, healthcare providers, and pharmacists to not use counterfeit Ozempic (semaglutide) injection 1 milligram, which has entered the U.S. drug supply chain. This counterfeit product is labeled with lot number NAR0074 and serial number 430834149057. FDA along with Novo Nordisk (manufacturer of Ozempic) are investigating this issue to determine the identity, quality, and safety of the counterfeit drugs. Additionally, it was found that the needles from these counterfeit samples can't be confirmed to be sterile, which could pose an increased risk of infection for patients. FDA is also aware of 5 non-serious adverse events from this lot, including nausea, vomiting, diarrhea, abdominal pain and constipation, which are common side effects of authentic Ozempic. You can see images of the affected product below.

The FDA advises retail pharmacies to source authentic Ozempic only through authorized distributors of Novo Nordisk to ensure the legitimacy of their shipments. It is recommended that patients only obtain Ozempic with a valid prescription through state-licensed pharmacies, and should check the product for any signs of counterfeiting.

RISKS

The US Food and Drug Administration (FDA) is investigating reports of potential side effects, including hair loss and suicidal thoughts, in individuals using medications containing semaglutide, such as Ozempic, Mounjaro, and Wegovy. Semaglutide, a GLP-1 receptor agonist, mimics the GLP-1 hormone to regulate insulin production, lower blood glucose, and reduce appetite. FDA approved three semaglutide products: Ozempic and Rybelsus for type 2 diabetes, with Ozempic also lowering heart-related risks, and Wegovy aiding weight loss in obesity.

Given the product shortages, there are compounding sales of these medications in the market, however, the FDA has received adverse event reports after patients used compounded semaglutide. This may be due to the use of salt forms of semaglutide. Products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products. Additionally, the FDA has discovered the distribution of illegally marketed semaglutide. These drugs may be counterfeit, which means they could contain the wrong ingredients, contain too little, too much or no active ingredient at all, or contain other harmful ingredients.

Semaglutide Medication

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.

In case you experience harm from this medication or the counterfeit product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Sources:
FDA Warning: www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain
FDA: www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
FDA: www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse

#ozempic #drugs #us

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