Reacción a "Reactions: EMA recommends that codeine-ibuprofen combination medicines warn of possible serious harm"

At the last meeting of the Pharmacovigilance Committee for Risk Assessment (PRAC) of the European Medicines Agency (EMA), held on 26-29 September, it was agreed to recommend to the national medicines agencies of European countries to include a new warning in the label and package leaflets of analgesic medicines containing a fixed-dose combination of codeine and ibuprofen. This warning refers to the potential for kidney damage and gastrointestinal damage, as well as abuse and dependence on codeine (an opioid agent) when these drugs are administered at higher doses than recommended and/or for a very long period of time, and is based on numerous cases reported to health authorities, including some fatal outcomes, particularly in countries where these drugs are dispensed without prescription, which is why the EMA also recommends that they should always be dispensed on prescription.

This EMA measure is quite appropriate, especially since analgesic agents are often overused and some of them, such as codeine and ibuprofen, are considered to be harmless drugs with few safety concerns. These pharmacovigilance measures are always to be welcomed, in the interests of greater safety in the consumption of medicines.