Pholcodine is registered to treat non-productive (dry) coughs, and is contained in a number of non-prescription medicines, either as a single active ingredient or in combination with other medicines. Picture: Max Pixel
Durban — Non-prescription medications for dry cough that contain pholcodine will be withdrawn from the South African market.
SA Health Products Regulatory Authority chief executive Dr Boitumelo Semete said this was due to the increased risk of sudden, severe and life-threatening allergic reactions occurring during surgery.
Pholcodine is registered to treat non-productive (dry) cough, and is contained in a number of non-prescription medicines, either as a single active ingredient or in combination with other medicines.
“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 are administered during general anaesthesia. The blocking agents are used as muscle relaxants during surgery. The use of pholcodine-containing medicines up to 12 months prior to surgery increases the risk of anaphylactic reaction in patients who receive blocking agents,” Semete said.
Semete said the available data provides convincing evidence to support the association of pholcodine use with the risk of developing an anaphylactic reaction to blocking agents, particularly when used in the 12 months prior to general anaesthesia. Furthermore, they said effective measures to minimise the risk of anaphylactic reactions to blocking agents, 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. Patients undergoing emergency surgery may not be able to provide information about their medical history to health-care professionals,” Semete said.
Furthermore, Semete said it had concluded that the potential risk outweighed the benefits, and as a precautionary measure pholcodine-containing medicines from the SA market would be withdrawn.
“Alternative medicines to treat a dry cough are available on the South African market, and consumers are advised to seek advice from their doctor or pharmacist in this regard.
“Moreover, patients should inform health-care professionals if they think they have taken a pholcodine-containing medicine, particularly in the 12 months prior to surgery or general anaesthesia,” Semete said.
South Africa would not be the only country to withdraw medicines containing pholcodine. The European Medicines Agency also recommended that these medicines be withdrawn from the European market.
WhatsApp your views on this story at 071 485 7995.
Daily News