Zimbabwe Bans Use Of Cough Medicine Containing Pholcodine
The Medicines Control Authority of Zimbabwe (MCAZ) has ordered healthcare professionals to advise patients to stop taking pholcodine-containing medicines.
Pholcodine is an opioid medicine that is used in adults and children for the treatment of non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and flu.
In Zimbabwe, pholcodine-containing products are marketed under the brand names Pholtex Plus and Pholtex Forte with the registration numbers 2018/22.2.5/5734 and 99/22.2.1/3624 respectively.
In a recent statement, MCAZ director general Richard Rukwata said:
MCAZ would like to advise all stakeholders of a significant safety issue with pholcodine-containing medicines.
Available data indicate that the use of pholcodine in the 12 months before general anesthesia with neuromuscular blocking agents (NMBA) such as suxamethonium, and atracurium is a risk factor for developing an anaphylactic reaction upon administration of the NMBA.
The Authority would like to draw the attention of all licensed pharmaceutical wholesalers, pharmacies, public and private clinics, and hospitals that they must quarantine the stated products.
… due to the seriousness of the safety risk, all pholcodine-containing products are being withdrawn from the Zimbabwean market.
Health care professionals, advise patients to stop taking pholcodine-containing medicines and consider appropriate alternatives to treat their symptoms.
Check whether patients scheduled to undergo general anesthesia with NMBAs have used pholcodine in the previous 12 months and remain aware of the risk of anaphylactic reactions in those patients.
The UK government says there is already a known link between pholcodine and an increased risk of the very rare event of a severe allergic reaction (anaphylaxis) to muscle relaxants (neuromuscular blocking agents) that are used during general anaesthesia in surgery.
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