The Nationwide Company for Meals and Drug Administration and Management (NAFDAC) has alerted the general public on falsified Oxycontin 80mg (oxycodone hydrochloride), which it says was detected in an unregulated market in Switzerland.
The general public alert with No. 07/2025 was uploaded on the company’s web site on Thursday.
The company stated the difficulty of the falsified medication was reported to the World Well being Organisation (WHO) by the real producer, MUNDIPHARMA, in February.
It stated the falsified product imitated the real OXYCONTIN 80mg authorised on the market in Poland, including that the real OXYCONTIN (oxycodone hydrochloride) is a semi-synthetic opioid indicated for the therapy of average to extreme ache.
It stated laboratory checks of samples for the falsified product have been performed by the Drug Data Centre in Zurich, Switzerland, and that WHO, DIZ’s drug-checking service, decided that the tablets didn’t comprise oxycodone however an artificial opioid prone to be a nitazene compound.
In line with NAFDAC, Nitazene derivatives (e.g., metonitazene, isotonitazene, fluonitazene) are potent artificial opioids primarily utilized in analysis as a consequence of their excessive habit potential and extreme unwanted effects.
It stated these substances may very well be lots of of occasions stronger than oxycodone, posing a excessive overdose threat, stressing that restricted info is out there on their dangers, toxicity, unwanted effects, and long-term penalties.
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NAFDAC stated, “The recognized product on this alert is confirmed as falsified on the premise that it intentionally/fraudulently misrepresented its identification, composition, or supply.
“The falsified product imitates OXYCONTIN 80mg manufactured and marketed by MUNDIPHARMA within the Polish market. MUNDIPHARMA has confirmed that the product was falsified and was not produced by their firm.
“This falsified product has been discovered to comprise undeclared nitazene compounds, which pose a major threat as a result of excessive probability of antagonistic occasions, even in small doses. Nitazenes produce related results to different opioids.
“Their excessive efficiency carries a excessive threat of overdose and demise. Utilizing nitazene derivatives has been linked to a number of deaths.
“Mixing them with different depressants like alcohol or benzodiazepines could be very harmful, resulting in extreme results like respiratory despair, low blood strain, coma, and even demise.”
It stated that this falsified product posed a selected threat to people with substance use problems who would possibly understand this falsified product as a protected and quality-assured medication.
NAFDAC stated that seen discrepancies have been noticed within the falsified product, comparable to the wrong placement of the batch and expiration dates on the counterfeit product.
It added that the falsified product batch and expiry date are seen on the entrance facet of the blister strip, including that real OXYCONTIN has the batch and expiry date seen on the again of the blister strip.
NAFDAC acknowledged that on the falsified product, the expiration date is on the left, and the batch quantity is on the suitable, mentioning that real OXYCONTIN has the batch quantity on the left and the expiration date on the suitable.
In line with NAFDAC, all its zonal administrators and state coordinators have been instructed to conduct surveillance and retrieve any falsified merchandise of this medication discovered inside their zones and states in Nigeria.
It stated that importers, distributors, retailers, healthcare professionals, and customers are hereby suggested to train warning and vigilance throughout the provide chain to keep away from importation, distribution, sale, and use of falsified OXYCONTIN tablets.
NAFDAC stated that every one medical merchandise/ medical units have to be obtained from authorised/licensed suppliers, stressing that merchandise’ authenticity and bodily situation ought to be fastidiously checked.
It suggested healthcare professionals and customers to report any suspicion of the sale of substandard and falsified medicines or medical units to the closest NAFDAC workplace, or name NAFDAC on 0800-162-3322 or through e mail: sf.alert@nafdac.gov.ng.
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It stated that healthcare professionals and sufferers are additionally inspired to report antagonistic occasions or unwanted effects associated to the usage of medicinal merchandise or units to the closest NAFDAC workplace.
NAFDAC stated that healthcare professionals and sufferers might additionally report back to the company by way of the usage of the E-reporting platforms out there on the NAFDAC web site www.nafdac.gov.ng or through the Med- security software out there for obtain on android and IOS shops or through e-mail on pharmacovigilance@nafdac.gov.ng (NAN)
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