EMA’s safety committee, PRAC, has concluded its review of medicines containing , which are used in adults children to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold flu, has recommended the revocation of the EU marketing authorisations for these medicines.
During the review, the PRAC evaluated all available evidence including the final results of the ALPHO study,1 post-marketing safety data information submitted by third parties such as healthcare professionals. The available data showed that use of pholcodine in the 12 months before general anaesthesia with neuromuscular blocking agents (NMBA) is a risk factor for developing an anaphylactic reaction (a sudden, severe life-threatening allergic reaction) to NMBAs.
As it was not possible to identify effective measures to minimise this risk, nor to identify a patient population for whom the benefits of pholcodine outweigh its risks, pholcodine-containing medicines are being withdrawn from the EU market will therefore no longer be available by prescription or over-the-counter.
Healthcare professionals should consider appropriate treatment alternatives advise patients to stop taking pholcodine-containing medicines. Healthcare professionals should also check whether patients scheduled to undergo general anaesthesia with NMBAs have used pholcodine in the previous 12 months, remain aware of the risk of anaphylactic reactions in these patients.
The PRAC recommendations will now be sent to the Coordination Group for Mutual Recognition Decentralised Procedures – Human (CMDh)2 for consideration at its next meeting in December 2022.
链接：https://www.ema.europa.eu/en/news/ema-recommends-withdrawal-pholcodine-medicines-eu-market
