The European Medicines Agencies (EMA) recommended European countries include new warnings on labels and in package inserts of analgesics, or pain killers, that combine codeine and ibuprofen. This recommendation was agreed at the last meeting of the Pharmacovigilance Risk Assessment Committee (PRAC), held at the end of September 2022.
The aim is to warn consumers of the potential effects these medicines may cause when they are administered at higher doses than recommended or for a very long period of time. These include kidney or gastrointestinal damage and metabolic disturbances, as well as codeine abuse and dependence. The EMA’s warning is based on numerous cases reported to health authorities in different European countries, including some with fatal outcomes.
