Information for pharmacists
The European Medicines Agency’s safety committee – the Pharmacovigilance Risk Assessment Committee (PRAC) – has recommended that the marketing authorisations for all pholcodine-containing medicinal products be withdrawn so that these medicines can no longer be marketed in the EU. This follows a review by PRAC which concluded there is a link between pholcodine use within the previous 12 months preceding general anaesthesia where neuromuscular blocking agents (NMBAs) are administered and a risk of anaphylactic reaction to NMBAs.
The PRAC recommendation is not the final step in the regulatory process. The recommendation will now be sent to the EUs Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position. The marketing authorisations for pholcodine-containing products remain valid until that time.
However, the HPRA wishes to highlight the current PRAC recommendation to withdraw the marketing authorisations and to provide advice to pharmacists pending finalisation of the regulatory process.
Day Nurse Capsules (Paracetamol 500mg Pseudoephedrine Hydrochloride 30mg Pholcodine 5mg), indicated for the relief of the major symptoms of colds and influenza for 16 year olds and over, is currently the only pholcodine- containing medicinal product marketed in Ireland.
For further information, see the letter for pharmacists linked below.
European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) recommends that pholcodine-containing medicinal products are no longer marketed