WHO issues alert on falsified Oxymorphone Hydrochloride 40mg in Europe

SWITZERLAND—The World Health Organization (WHO) has issued a medical product alert regarding a falsified batch of Oxymorphone Hydrochloride 40mg with deliberate misrepresentation of its identity, composition, and source.

This alert follows a report from the Finnish Medicines Agency (FIMEA), which discovered the counterfeit product in Finland’s unregulated supply chain in July 2024 and subsequently notified WHO.

According to FIMEA, the falsified drug lacked a barcode on the bottle and was misleadingly labelled as 40mg, while the authentic Oxymorphone Hydrochloride from AUROLIFE PHARMA is only available in 5mg and 10mg doses.

Additionally, the counterfeit tablets did not feature the embossed letters or numbers found on the genuine product and were missing the National Drug Code (NDC) of the United States of America.

AUROLIFE PHARMA LLC confirmed that the product in question was falsified and not manufactured by their company.

Oxymorphone Hydrochloride is a semi-synthetic opioid that is typically used to manage moderate to severe pain.

 However, laboratory analysis of the falsified product revealed that the tablets contained metonitazene instead.

Metonitazene is a potent psychoactive synthetic opioid with no officially recognized or authorized medicinal or therapeutic use.

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

The presence of metonitazene in the falsified product poses significant health risks, with small doses of the substance capable of leading to serious adverse effects such as respiratory depression, severe sedation, addiction, and potentially fatal overdose.

In their statement, WHO has emphasized that the falsified product was likely designed to mimic those authorized by the U.S. Food and Drug Administration (FDA) and marketed by AUROLIFE PHARMA LLC.

This falsified product with undeclared metonitazene poses a considerable threat to users due to its high potency and associated risks of overdose and death.

In response, the WHO has urged healthcare professionals, regulatory authorities, and the public to be vigilant.

Healthcare professionals have been advised to report any adverse effects, lack of expected effects, or suspected falsification to their National Regulatory Authorities or the National Pharmacovigilance Centre.

Additionally, WHO has recommended increased surveillance and diligence within supply chains, particularly in regions likely to be affected by these falsified products.

The WHO has also called for heightened informal and unregulated market monitoring, with national regulatory authorities, health authorities, and law enforcement agencies advised to immediately notify the WHO if the falsified product is detected in their jurisdiction.

WHO has also advised individuals possessing the falsified products not to use them.

Those who know individuals who have used these products or suffered adverse events have been advised to seek immediate medical advice from healthcare professionals or contact a poison control center.