The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert regarding counterfeit Oxycontin 80mg (oxycodone hydrochloride) detected in an unregulated market in Switzerland.
The alert, numbered No. 07/2025, was posted on NAFDAC’s website on Thursday, March 20.
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The issue of the falsified product was reported to the World Health Organisation (WHO) by the legitimate manufacturer, MUNDIPHARMA, in February.
Laboratory tests reveal counterfeit tablets contain synthetic opioid, not oxycodone
NAFDAC explained that the counterfeit product resembled the genuine Oxycontin 80mg authorised for sale in Poland. The authentic Oxycontin, a semi-synthetic opioid, is used for managing moderate to severe pain.
Laboratory testing conducted by the Drug Information Centre in Zurich, Switzerland, confirmed that the falsified tablets did not contain oxycodone. Instead, they contained a synthetic opioid, likely a nitazene compound.
Nitazene derivatives, such as metonitazene, isotonitazene, and fluonitazene, are potent opioids primarily used in research due to their high addiction potential and severe side effects.
NAFDAC warned that nitazene compounds could be hundreds of times stronger than oxycodone, posing a significant risk of overdose.
The agency highlighted the limited information available on the toxicity, side effects, and long-term consequences of these substances.
NAFDAC identifies discrepancies in counterfeit oxycontin
The counterfeit product, NAFDAC confirmed, was deliberately misrepresented, imitating Oxycontin 80mg manufactured by MUNDIPHARMA for the Polish market. The company confirmed that the product was not produced by them.
The falsified tablets were found to contain undeclared nitazene compounds, which can cause severe adverse effects, even in small doses. NAFDAC pointed out that nitazene derivatives produce similar effects to other opioids but carry a high overdose risk.
Mixing them with depressants such as alcohol or benzodiazepines could lead to dangerous outcomes, including respiratory depression, low blood pressure, coma, and death.
The agency also noted that the falsified product posed a particular danger to individuals with substance use disorders, who might mistakenly perceive it as a safe and genuine medicine.
Several discrepancies were identified in the falsified product, including the incorrect placement of batch and expiry dates.
On the counterfeit blister strip, the batch number appeared on the right, and the expiry date on the left, whereas the genuine Oxycontin had the batch number on the left and the expiry date on the right.
Additionally, the batch and expiry dates on the falsified product were printed on the front side of the blister strip, unlike the genuine product, where they appear on the back.
NAFDAC encourages reporting of adverse events
NAFDAC reportedly instructed all zonal directors and state coordinators to conduct surveillance and remove any falsified Oxycontin found within their zones and states in Nigeria.
Importers, distributors, retailers, healthcare professionals, and consumers have been urged to exercise caution and vigilance to prevent the importation, distribution, sale, and use of counterfeit tablets.
The agency emphasised the importance of obtaining medical products and devices only from authorised and licensed suppliers.
Healthcare professionals and consumers were also advised to report any suspicions of substandard or falsified products to NAFDAC through its website, customer service hotline, or email.
Additionally, NAFDAC encouraged the reporting of adverse events or side effects related to medicinal products or devices via its E-reporting platforms or the Med-Safety app, available on Android and iOS.
