The World Health Organization (WHO) has issued a warning about counterfeit painkillers for severe pain found in Finland’s unregulated drug market.

Oxymorphone Hydrochloride 40mg, a semi-synthetic opioid used to treat moderate to severe pain was reported to WHO in July 2024 by the Finnish Medicines Agency (FIMEA).

Laboratory analysis of samples of the falsified product, however, found that the tablets contained metonitazene instead, according to WHO.

Metonitazene is a strong drug that can change how you think and feel. It is not meant to be used as a medicine and has no official medical purpose.

It is under international control as a Schedule I narcotic drug following recommendations of the WHO Expert Committee on Drug Dependence in 2021.

Small doses can result in serious adverse effects such as respiratory depression, severe sedation, and addiction, and an overdose may be fatal.

How to identify counterfeit

According to WHO, the product deliberately misrepresents its identity, composition, and source.

The falsified product imitates Oxymorphone Hydrochloride marketed by AUROLIFE PHARMA LLC., who have confirmed that the product, subject of this Alert, is falsified and was not produced by their company.

To identify the counterfeit product, buyers and sellers should check for a barcode on the bottle. The authentic product will have a barcode on its label. The falsified version label does not have a barcode on the bottle.

The falsified version is labelled 40mg. AUROLIFE PHARMA Oxymorphone Hydrochloride is only available in 5mg and 10mg doses.

The falsified versions of the tablets lack embossed letters and numbers. The falsified product’s label is missing the National Drug Code of the United States of America.

This falsified product may have been intentionally designed to mimic products authorized by the U.S. Food and Drug Administration and marketed by AUROLIFE PHARMA LLC as Oxymorphone Hydrochloride.

However, it contains undeclared metonitazene, which poses a significant risk to users due to the high likelihood of adverse events, even in small doses. Metonitazene produces effects similar to other opioids.

Its high potency carries a high risk of overdose and death. Use of this falsified product may be life-threatening.

Healthcare professionals should report any incident of adverse effects, lack of expected impacts, or suspected falsification to the National Regulatory Authorities/National Pharmacovigilance Centre, WHO urged.

“If you have any of these products, WHO recommends not using them; if you, or someone you know, has, or may have used these products, or suffered an adverse event or unexpected side-effect after use, seek immediate medical advice from a healthcare professional or contact a poisons control centre,” WHO stated in the public alert.

“All medical products must be obtained from authorized/licensed suppliers. If you have any information about the manufacture or supply of these falsified products, please get in touch with WHO via rapidalert@who.int,” it added. (BusinessDay)

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