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Withdrawal of Pholcodine-Containing Medicines in Singapore
The Health Sciences Authority (HSA) would like to inform the public that all medications containing pholcodine will no longer be available in Singapore. The company responsible for selling these products, iNova Pharmaceuticals (Singapore) Pte Ltd, is discontinuing the registration and distribution of these medications containing pholcodine within the local market. This action is being taken as a precautionary step due to reports from abroad indicating a rare and minimal risk of severe allergic reactions (such as anaphylaxis) to muscle relaxants (referred to as neuromuscular blocking agents or NMBAs) used during general anesthesia in individuals who have recently consumed pholcodine, especially in the preceding year.
Pholcodine is one of the medicines utilized for the treatment of dry cough. In Singapore, medications containing pholcodine have been officially registered since 1993 and are categorized as pharmacy-only products, exclusively accessible through healthcare professionals like doctors and pharmacists.
Table 1. List of pholcodine-containing medicines registered as pharmacy-only medicines in Singapore
- Duro-Tuss® Forte Cough Liquid 45mg/15mL
- Duro-Tuss® Regular Cough Liquid 15mg/15mL
- Duro-Tuss® Expectorant Cough Liquid
- Duro-Tuss® Dry Cough Lozenges (Orange flavoured)
- Difflam® Blackcurrant Sugar Free Cough Lozenges
- Duro-Tuss® Decongestant Linctus [Not marketed locally]
- Duro-Tuss® Lemon Dry Cough Lozenges [Not marketed locally]
A safety investigation known as the ALPHO study [1], carried out in France, revealed a connection between pholcodine and a heightened likelihood of anaphylaxis when used in conjunction with NMBAs during general anesthesia for surgical procedures. This safety concern, while uncommon, has been evaluated as exceedingly minimal. Thus far, the Health Sciences Authority (HSA) has not received any local reports indicating instances of anaphylactic reactions linked to NMBAs and suspected to be associated with pholcodine.
HSA has undertaken a thorough assessment of the aforementioned study and other pertinent safety information. After consultation with medical experts from its Product Vigilance Advisory Committee, HSA has reached the conclusion that the potential hazards surpass the benefits of pholcodine-containing medications. Therefore, as a precautionary measure, these products should be withdrawn from the local market.
Patient advisory
If you are preparing for a surgical procedure that requires general anesthesia and have consumed any medications containing pholcodine, especially within the previous year, it’s important to notify your anesthesiologist or physician. The occurrence of anaphylaxis during surgeries is an extremely uncommon event. Anesthesiologists are proficient in handling anaphylactic reactions and will factor this information into your surgical care.
Should you have any inquiries or apprehensions regarding the pholcodine-containing medications you are using, or if you are seeking guidance on alternative remedies for dry cough, it is advisable to consult your doctor or pharmacist.
HEALTH SCIENCES AUTHORITY
SINGAPORE
22 JUNE 2023
References:
[1] https://www.bjanaesthesia.org/article/S0007-0912(23)00104-6/fulltext
Link to the full News (HSA):
https://www.hsa.gov.sg/announcements/news/withdrawal-pholcodine-containing-medicines
