The Committee for Medicinal Products for Human Use (CHMP) has begun looking at the potential link between the use of pholcodine-containing medicines and anaphylactic reactions in patients subsequently exposed to neuromuscular blocking agents (NMBA) used in anaesthesia.  This follows the publication of studies suggesting that pholcodine induces immunologic stimulation in exposed individuals, and the observation that a decrease in reports of NMBA-related anaphylaxis has been observed in some Member States where pholcodine is no longer marketed.  

The CHMP will review all available data and will assess their impact on the balance of risks and benefits of pholcodine-containing medicines.  The Committee will then make recommendations on whether the marketing authorisations for these medicines should be maintained, changed, suspended or revoked.