Flash VIG-news : Dispensation of pholcodine-containing medicinal products suspended due to the risk of allergic cross-reactivity with neuromuscular blocking agents
October 3, 2022
Due to concerns about the risk of anaphylactic reactions, the dispensation of pholcodine-containing medicinal products is suspended from 1 October 2022.
Source: FAMHP
Concerns about the risk of anaphylactic reactions (sudden, severe and potentially fatal allergic reactions) triggered by certain medicinal products called neuromuscular blocking agents (NMBAs) have prompted the European Medicines Agency (EMA) to re-evaluate the benefit-risk balance of pholcodine-based medicinal products.
Pholcodine is a morphine derivative that is used to treat non-productive (dry) cough in children and adults. Pholcodine acts primarily on the central nervous system, which depresses the cough reflex.
Neuromuscular blocking agents (NMBAs) are used during general anaesthesia to prevent spontaneous muscle movements so that the operation can be executed under better conditions.