Today the European Union has decided to subject the new synthetic opioid furanylfentanyl to control measures throughout the EU (1). The implementing decision of the Council of the EU (2), based on an initial proposal by the European Commission, was adopted in the final stage of the three-step legal procedure designed to respond to potentially threatening new psychoactive substances (NPS) available on the market (3)(4). The substance in question has been raising health concerns in Europe after harmful effects related to its use were reported by the Member States through the EU Early Warning System (EWS), which is implemented by the EMCDDA and Europol. Following publication of the decision in the Official Journal of the European Union, Member States will have one year to introduce the controls into national legislation.
The decision is based on the findings of a formal risk assessment of the drug, conducted by the extended EMCDDA Scientific Committee on 23 May 2017, with participation of additional experts from the EU Member States, European Commission, Europol and the European Medicines Agency. The risk assessment report assessed the health and social risks of the drug, as well as international trafficking and the involvement of organised crime (5). It concluded that the high potency of the substance constitutes a serious risk of acute toxicity through respiratory depression.
Furanylfentanyl is structurally related to fentanyl (a controlled substance widely used in medicine as an adjunct to general anaesthesia during surgery and for pain management). Available in the EU since at least June 2015, furanylfentanyl is sold as a ‘research chemical’ and as a ‘legal’ replacement to illicit opioids. It has no established or acknowledged medical value or use in the EU. Information from seizures shows that some furanylfentanyl on the market in Europe has been produced by chemical companies based in China.
Furanylfentanyl has been seized in powder and liquid form, including ready-to-use nasal sprays. It has also been sold as e-liquids for vaping in electronic cigarettes. At the time of the risk assessment (May 2017), it had been detected in 16 EU Member States and Norway, with 23 deaths associated with the substance reported by six EU countries. Clinical experience suggests that naloxone works as an antidote to poisoning caused by the drug.
In Europe and in North America, highly potent synthetic opioids are a growing health threat. Twenty-five new synthetic opioids were detected in Europe between 2009 and 2016 (18 of these were fentanils). Of the nine risk assessments carried out by the EMCDDA and its partners in 2017, five were fentanils (acryloylfentanyl, furanylfentanyl, 4F-iBF, carfentanil and THF-F).