The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public about the circulation of pre-filled pens falsely labeled as the diabetes medicine, Ozempic (semaglutide, 1 mg, solution for injection) which was identified at wholesalers in the European Union and the UK as reported by the European Medicines Agency (EMA).
The reports of falsification came in the wake of an increase in demand for Ozempic, which has led to a global shortage situation. The pens have batch numbers, 2D barcodes, and unique serial numbers from genuine Ozempic packs.
All affected pens have been recalled and accounted for, and none of the pens have been supplied to UK patients. There is also no evidence that any falsified pens have been dispensed to patients from legal pharmacies and there are no reports of harm to patients with the falsified medicine in the EU or UK.
There are differences in appearance between the falsified pen and the original pen. Here is a picture of the original and falsified pen as published by the German Medicines Agency.
Semaglutide is an antidiabetic medication used for the treatment of type 2 diabetes and an anti-obesity medication used for long-term weight management. It is also used to lower the risk of heart attack, stroke, or death in patients with type 2 diabetes and heart or blood vessel disease. It should be noted that Ozempic (semaglutide) is not registered by NAFDAC.
Although the product is not in NAFDAC database, it is likely that it might have been distributed in the country through informal markets.
NAFDAC implores importers, distributors, retailers and healthcare providers and patients to always exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and administration or use of falsified or substandard medicinal products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
If you have this falsified product, please DO NOT use it. If you, or someone you know, have used the product, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC……….Customer-focused, Agency-minded!!!
Signed Management
References
https://www.ema.europa.eu/en/news/ema-alerts-eu-patients-healthcare-professionals-reports-falsified-ozempic-pens#:~:text=The%20European%20Medicines%20Agency%20has,the%20EU%20and%20the%20UK
https://www.gov.uk/government/news/falsified-ozempic-semaglutide-pens-identified-at-two-wholesalers-in-the-uk
https://www.bfarm.de/DE/Arzneimittel/Arzneimittelinformationen/Rapid-Alert-System/Arzneimittelfaelschungen/Ozempic/_artikel.html?nn=468782
https://www.mayoclinic.org/drugs-supplements/semaglutide-subcutaneous-route/description/drg-20406730
