EMA. Methadone: Periodic Safety Update Report Single Assessment zu Methadon - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
EMA. Methadone: Periodic Safety Update Report Single Assessment zu Methadon - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Scientific conclusions
Taking into account the PRAC Assessment Report on the PSUR(s) for methadone, the scientific conclusions are as follows:
In view of available data on sphincter of Oddi dysfunction as a class effect for opioids, the PRAC considers a causal relationship between methadone and sphincter of Oddi dysfunction is at least a reasonable possibility. The PRAC concluded that the product information of products containing methadone should be amended accordingly.
In view of available data on hyperalgesia from the scientific literature, the PRAC considers a causal relationship between methadone and hyperalgesia is at least a reasonable possibility. The PRAC concluded that the product information of products containing methadone indicated in the treatment of pain should be amended accordingly.
In view of available data on examining congenital malformations and neurodevelopmental impairment in children born to opioid-dependent mothers from the scientific literature and observational studies, the PRAC considers a causal relationship between methadone exposure and congenital malformations and neurodevelopmental impairment in children born to opioid-dependent mothers is at least a reasonable possibility. The PRAC concluded that the product information of products containing methadone should be amended to reflect the available evidence. (EMA European Medicines Agency, März 2026)