Chronicle Editor
Judith Phiri, Sunday News Reporter
THE Medicines Control Authority of Zimbabwe (MCAZ) has instructed healthcare professionals to advise patients to stop taking pholcodine-containing medicines and consider appropriate alternatives to treat their symptoms.
Pholcodine is an opioid medicine that is used for the treatment of non-productive (dry) cough in children and adults and is normally not sold without a prescription from a medical professional. It works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing.
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 statement, MCAZ director general Mr Richard Rukwata said there must be quarantine all pholcodine-containing products.
“MCAZ would like to advise all stakeholders of a significant safety issue with pholcodine-containing medicines. Available data indicates 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.”
He said the hypothesis that pholcodine use could trigger anaphylactic reactions to NMBAs was based on the body producing antibodies against pholcodine, which eventually trigger reactions to NMBAs (cross-sensitisation).
Mr Rukwata said the authority noted that there were no effective measures to minimise this risk, nor was there an identified patient population for whom the benefits of pholcodine outweigh its risks.
“As such, due to the seriousness of the safety risk, all pholcodine-containing products are being withdrawn from the Zimbabwean market. For 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,” he added.
He said for consumers, if they need general anesthesia and have taken a pholcodine containing medicine in the past 12 months, they should advise their healthcare professionals prior to undergoing the procedure. Mr Rukwata said before this instruction for recall, registered pharmacies and pharmaceutical wholesalers were allowed to sell the two medicines that contain pholcodine (Pholtex Plus and Pholtex Forte).
“They are not over the counter medicines as Pholtex forte could be obtained after consultation with a pharmacist (pharmacist initiated medicines), while Photex Plus could be obtained if one has a valid prescription (prescriptions preparations).”
Online Reporter