The South African Health Products Regulatory Authority (Sahpra) has withdrawn all pholcodine-containing medicines from the market due to the increased risk of sudden, severe and life-threatening allergic reactions occurring during surgery, reports MedicalBrief.
This follows a local probe launched last month after a global withdrawal, reported in MedicalBrief, of all medicines containing the opioid, and after authorities in Britain, the European Union and Australia pulled them from the market with safety concerns.
Pholcodine works by binding to opioid receptors in the brain and reducing nerve signals sent to muscles involved in coughing.
It has been used as a cough suppressant since the 1950s.
Sahpra noted the link between these medicines and the risk of a sudden, severe and life-threatening allergic (anaphylactic) reaction when neuromuscular blocking agents (NMBAs) are administered during general anaesthesia. 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.
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 yet 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, while anyone having emergency surgery might not be able to provide information about their medical history to healthcare professionals, warned Sahpra.
Pholcodine is registered to treat dry coughs and is available in various non-prescription medicines, either as a single active ingredient or in combination with other drugs.
Sahpra said it was working with the manufacturers to ensure that all pholcodine-containing medicines are removed from the market i.e. pharmacies, distributors, wholesalers or authorised health facilities, and has urged people to stop using these drugs and return them to pharmacies.
SAHPRA notification – SAHPRA Withdraws Pholcodine-Containing Medicines From SA Market (Open access)
See more from MedicalBrief archives:
Sahpra probes coug h medicines after global withdrawals
Doctors more likely to recommend antihistamines than cough and cold medicine for kids
Parents too quick to medicate children’s fevers – US poll