(NewsInsights.org) – US and EU health agencies monitor the distribution of pharmaceuticals closely to ensure the medications people use are authentic, safe, and traceable. Unfortunately, a counterfeit supplier has health authorities worldwide issuing warnings to pharmacies, doctors, and patients over fake shipments of Ozempic, a diabetic medication that many physicians have also prescribed off-label as a weight-loss drug.
Ozempic and a similar drug, Wegovy, have become extremely popular prescriptions throughout the US and Europe, resulting in shortages dating back to March 2022. Novo Nordisk is the only authorized manufacturer of the drugs. However, chronic shortages have led to counterfeiters claiming to sell the medications.
The FDA issued its most recent warning on December 21, 2023. The agency cautioned it was investigating one-milligram Ozempic self-injectible doses in the US supply chain after seizing thousands of units of counterfeit medication. The FDA asked patients, healthcare providers, retail pharmacies, and wholesalers to check product labels, making sure not to use, sell, or resell any products labeled with Lot Number NAR0074 and Serial Number 430834149057.
The FDA said it and the manufacturer were testing the seized product to discover what the injections contained. Another issue was that the agency could not ensure the counterfeit self-injectible medications used sterile needles to deliver dosages, raising infection concerns. The FDA received five reports of adverse events associated with the seized lot of fake medication. However, the agency said people experienced events consistent with taking Ozempic, including nausea, diarrhea, vomiting, constipation, and abdominal pain.
The European Medicines Agency issued a similar warning in October 2023 after finding counterfeit medicines in the UK and EU countries. Authorities reported that several Austrian patients who used those fake products, which contained insulin, suffered hypoglycemia and seizures, landing them in the hospital. German Authorities also found counterfeit injections containing insulin in November 2023
Without insurance, Ozempic prescriptions, if patients can find the drug available, can cost up to $1000 per month. Yet, for many who can tolerate the medication, it has eliminated the need for other type II diabetic treatments. It has also resulted in significant weight loss for some patients, reducing or eliminating other medical comorbidities like high blood pressure, heart disease, some kidney ailments, and some lung disorders.
Ozempic and Wegovy are a type of Semaglutide, a glucagon-like peptide-1 (GLP-1) agonist with amino acid substitutions in specific positions on the peptide chain. They send a message to the patient’s brain, indicating satiety and fullness after a meal and prompting the brain to release insulin.
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