“The main difference between the counterfeit product and the genuine product is that the genuine Novo Nordisk Ozempic pens do not extend or increase in length when setting the dose. The scale drum increments are fixed doses, such as 0.25 mg, 0.5 mg, and 1.0 mg for Ozempic pens,”
The National Agency for Food and Drugs Administration and Control (NAFDAC) on Sunday raised the alerm over what it called falsified is Ozempic (Semaglutide) Pen, used for administering insulin on diabete patients.
The agency said there is a batch of the falsified pen saying that its
Marketing Authorization Holder (MAH) Novo Nordisk, has also confirmed that Ozempic (Semaglutide) Injection Pen withbatch number MP5B060is falsified.
The agency said thisfollowed an enquiry received from a customer about the product.
“Although, no sample was returned to Novo Nordisk affiliate in Nigeria for investigation, the picture of the falsified product provided was scrutinized and the image of the pen in the picture was observed to be different from that in the genuine product confirming the falsified status of the suspected fake product,” NAFDAC stated
The agency said Novo Nordisk, confirmed there were numerous cases related to the issue on falsified Ozempic originating from the Middle East and Russia. The affected countries include Azerbaijan, Egypt, Iraq, Jordan, Lebanon, Turkey, Uzbekistan and Russia.
NAFDAC stated, “Investigation conducted on the received falsified pens concludes that the pens are relabelled Apidra Solostar pen. The content of one of the pens was analysed and found to contain the fast-action insulin glulisin which is believed to be the case in all the falsified Ozempic pens identified. This implies the content of the falsified pens is entirely different from the genuine product.
“The main difference between the counterfeit product and the genuine product is that the genuine Novo Nordisk Ozempic pens do not extend or increase in length when setting the dose. The scale drum increments are fixed doses, such as 0.25 mg, 0.5 mg, and 1.0 mg for Ozempic pens,” it said
NAFDAC explained further that a falsified pen can be identified based on scale going from 0 to 80 units and extending out from the pen when setting the dose.
“The falsified products have been sold both within the legal and illegal supply chain.
“Ozempic®(semaglutide) injection 0.5 mg, 1 mg, or 2 mg is an injectable prescription medicine. It is a once-weekly medicine for adults with type 2 diabetes used to improve blood sugar, along with diet and exercise. It also helps to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.
“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, pleaseDO 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 adverse drug reaction, substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email:sf.alert@nafdac.gov.ng”