Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, (EMA) has recommended the revocation of marketing authorisation for medicines containing pholcodine as an active substance in the EU Member States.

Regarding this matter, the Institute for Medicines and Medical Devices (CInMED) would like to inform expert and general public that no marketing authorisation for any medicine containing pholcodine as an active substance has been issued in Montenegro. Additionally, after 2016, no import of unauthorised medicines (medicines without marketing authorisation) containing pholcodine as an active substance has been approved.

Pholcodin is a medicine that was used for many years to treat dry cough in children and adults. Previously, it was marketed in Montenegro under names Pholcodin, capsule, 10mg, Pholcodin syrup, 4mg/5ml and Pholcodin syrup 5mg/5ml, manufactured by Alkaloid AD Skopje. CInMED did not receive any report of adverse reactions to these medicines.

When assessing the safety of medicines containing pholcodine, PRAC analyzed all available data, including results of recently conducted ALPHO study. The available data showed that the use of pholcodine in the period of 12 months before general anesthesia administered with neuromuscular blocking agents is associated with the risk of development of an anaphylactic reaction (severe life-threatening allergic reaction). Due to the fact that it was not possible to identify measures that would reduce this risk, nor the group of patients for whom the benefit-risk ratio was favorable, it was recommended to withdraw this medicine from the market. PRAC recommendation will be sent to the EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which will, then, send its decision to the European Commission whose decision is legally binding for all EU Member States.