NAFDAC Alerts Nigerians On Falsified Oxycontin 80mg
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert regarding falsified Oxycontin 80mg (oxycodone hydrochloride) found in an unregulated market in Switzerland.
The alert, numbered 07/2025, was published on NAFDAC’s website on Thursday. According to the agency, the counterfeit medication was reported to the World Health Organization (WHO) by its genuine manufacturer, MUNDIPHARMA, in February.
NAFDAC explained that the falsified product mimicked the authentic OXYCONTIN 80mg authorized for sale in Poland. Genuine OXYCONTIN, which contains oxycodone hydrochloride, is a semi-synthetic opioid prescribed for moderate to severe pain relief.
Laboratory tests conducted by the Drug Information Centre in Zurich, Switzerland, revealed that the counterfeit tablets contained no oxycodone. Instead, WHO and DIZ’s drug-checking service identified a synthetic opioid, likely a nitazene compound.
Nitazene derivatives, such as metonitazene, isotonitazene, and fluonitazene, are highly potent synthetic opioids primarily used in research due to their strong addictive potential and severe side effects.
NAFDAC warned that these substances could be hundreds of times stronger than oxycodone, significantly increasing the risk of overdose. The agency emphasized that there is limited information on their risks, toxicity, side effects, and long-term health impacts.
“The identified product in this alert is confirmed as falsified on the basis that it deliberately/fraudulently misrepresented its identity, composition, or source.
“The falsified product imitates OXYCONTIN 80mg manufactured and marketed by MUNDIPHARMA in the Polish market. MUNDIPHARMA has confirmed that the product was falsified and was not produced by their company.
“This falsified product has been found to contain undeclared nitazene compounds, which pose a significant risk due to the high likelihood of adverse events, even in small doses. Nitazenes produce similar effects to other opioids.
“Their high potency carries a high risk of overdose and death. Using nitazene derivatives has been linked to several deaths.
“Mixing them with other depressants like alcohol or benzodiazepines can be very dangerous, leading to severe effects like respiratory depression, low blood pressure, coma, or even death,” NAFDAC said.
NAFDAC cautioned that the falsified Oxycontin 80mg poses a significant danger, particularly to individuals with substance use disorders who may mistakenly believe it to be a safe and quality-assured medication.
The agency identified visible discrepancies in the counterfeit product, including incorrect placement of the batch and expiry dates. Unlike the genuine OXYCONTIN, where these details appear on the back of the blister strip, the falsified version displays them on the front. Additionally, in the counterfeit product, the expiry date is positioned on the left and the batch number on the right—opposite to the correct format in authentic OXYCONTIN.
To curb the circulation of the falsified product, NAFDAC has directed its zonal directors and state coordinators to conduct surveillance and remove any counterfeit versions found in their respective areas across Nigeria.
The agency urged importers, distributors, retailers, healthcare professionals, and consumers to exercise caution throughout the supply chain to prevent the importation, distribution, sale, and use of falsified OXYCONTIN tablets.
NAFDAC emphasized that all medical products and devices should only be obtained from authorized or licensed suppliers. It also advised thorough verification of product authenticity and physical condition before use.
Healthcare professionals and consumers are encouraged to report any suspected cases of substandard or falsified medicines or medical devices to the nearest NAFDAC office. Reports can also be made by calling 0800-162-3322 or via email.
3/21/2025, 7:38:58 AM
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