The Medicines Control Authority of Zimbabwe (MCAZ) has halted the use of medicines containing the pholcodine substance after learning it causes life threatening adverse reactions.
By Kuda Pembere
In a statement, MCAZ Director General Mr Richard Rukwata said they found that use of pholcodine a year before general anasthesia had high risk of getting anaphylactic reactions.
Available data indicated that the use of pholcodine in the twelve (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 hypothesis that pholcodine use could trigger anaphylactic reactions to NMBAs is based on the body producing antibodies against pholcodine, which eventually trigger reactions to NMBAs (cross-sensitization),” he said.
Pholcodine is an opioid medicine that is used for the treatment of non-productive (dry) cough in children and adults.
“It works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing.
” Pholcodine-containing products am marketed in Zimbabwe 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,” Mr Rukwata said.
He said no measures to reduce the risk have been found yet hence the Authority’s decision to stop the distribution and use of pholcodine products.
” The Authority noted that there are no effective measures to minimize this risk, nor is 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 As such, due to the seriousness of the safety risk, all pholcodine-containing products are being withdrawn from the Zimbabwean market,” Mr Rukwata said.
He said healthcare professionals should, “…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.”
Patients taking pholcodine-containing medicine in the past 12 months should notify their healthcare providers before anesthesia.
