08/04/2023
The South African Health Products Regulatory Authority (SAHPRA) has decided to withdraw pholcodine-containing medicines from the market due to the increased risk of sudden, severe, and life-threatening allergic reactions occurring during surgery.
BY: TImesLIVE - Fri, 07 Apr 2023 13:48:23 GMT
If you are using these non-prescription medicines for a dry cough, stop using them.
The South African Health Products Regulatory Authority (SAHPRA) has decided to withdraw pholcodine-containing medicines from the market due to the increased risk of sudden, severe, and life-threatening allergic reactions during surgery.
“There is a link between the use of pholcodine-containing medicines and the risk of a sudden, severe and life-threatening allergic (anaphylactic) reaction when neuromuscular blocking agents (NMBAs) are administered during general anaesthesia,” the authority says. NMBAs are used as muscle relaxants during surgery. The use of pholcodine-containing medicines, up to 12 months before surgery, increases the risk of anaphylactic reaction in patients who receive NMBAs.
“The available data provides convincing evidence to support the association of pholcodine use with the risk of developing an anaphylactic reaction to NMBAs, particularly when used in the 12 months prior to general anaesthesia.
“Effective measures to minimise the risk of anaphylactic reactions to NMBAs, or to identify a patient population for whom the benefits of pholcodine outweigh its risks, have not been identified. As pholcodine is a non-prescription medicine, available patient records may not list its use, and patients may not always recall whether they have taken pholcodine-containing medicines in the past. Also, patients undergoing emergency surgery may not be able to provide information about their medical history to healthcare professionals.
“Pholcodine is registered to treat dry cough and is available in a number of non-prescription medicines, either as a single active ingredient or in combination with other medicines.
“In consideration of the nature of the adverse reaction, including its unpredictability and severity, SAHPRA has concluded that the potential risk outweighs the benefits. As a precautionary measure, SAHPRA has taken a regulatory decision to withdraw pholcodine-containing medicines from the South African market.”
SAHPRA is working together with the manufacturers to ensure that all pholcodine-containing medicines (PHOLTEX FORTE®, PHOLTEX JUNIOR®, PROCOF®, FOLCOFEN®, PHOLTEX PLUS®, ADCO-PHOLCOLINT®, CONTRA-COFF®, DOCSED®, TIXYLIX®) are removed from pharmacies, distributors, wholesalers or authorised health facilities.
The public is urged to stop using these medicines and return them to the pharmacies.
TimesLIVE
