Calls to Restrict Availability of Cough Medicines and Lozenges Not Supported by Firm Evidence

07 May 2013

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7 May 2013 - Peak industry body, the Australian Self Medication Industry (ASMI) has moved to reassure consumers that cough medicines and lozenges containing pholcodine can continue to be used, as directed, for the treatment of non-productive (dry) cough.

The advice is in response to recent media coverage in which the Australian and New Zealand Anaesthetic Allergy Group called for restrictions on the availability of pholcodine-containing cough medicines. These calls were made on the basis that there is a rare chance that a small group of patients may be at increased risk of anaphylaxis (a severe allergic reaction) when using neuromuscular blocking agents for some types of surgeries. [1]

While ASMI supports any future studies reviews investigating the possibility of an association between pholcodine and analphylatic reactions to neuromuscular blocking agents, there is a concern that statements from the group may cause undue alarm and confusion among consumers and healthcare professionals.

"Consumers and healthcare professionals are reminded that the benefits of pholcodine continue to outweigh its risks for the treatment of non-productive cough, and that no new risks have been identified with cough medicines and lozenges containing pholcodine," said Steve Scarff, ASMI's Scientific and Regulatory Affairs Director.

Mr Scarff added that any calls to restrict the availability of these medicinal substances should be based on firm evidence rather than associations with unproven causality.

"Pholcodine has been used as a cough suppressant since the 1950s. It has an established safety profile and remains an efficacious pharmacy-only cough suppressant option.

"The issue that the group has raised concerns the rare potential of pholcodine to trigger increased sensitivity to neuromuscular blocking agents in a small number of people. The precise mechanism of action has not been established. This issue is around immune sensitivity to unrelated chemicals and does not relate to a drug interaction.

"While the association of exposure to pholcodine and anaphylaxis to some neuromuscular blocking agents has been the subject of discussion for a number of years, no causal link has been proven, and the incidence of these types of anaphylaxis reactions is extremely rare."

The Therapeutic Goods Administration (TGA), Australia's regulatory agency for medical drugs and devices, has confirmed that its own recent review of available evidence did not appear to support any association. [2]

Likewise, the European Medicines Agency reviewed the available evidence and concluded that the benefits of pholcodine in the treatment of dry cough outweigh the risks, and that the benefit-risk profile of pholcodine-containing products in the treatment of dry cough is positive under normal circumstances .[3-5]

ASMI has offered the following advice to consumers and healthcare professionals:

  • If patients are going into hospital for an operation and have taken any medicines - both prescription and non-prescription - they should discuss that use with their healthcare professional as a matter of course.
  • Likewise, healthcare professionals should be routinely asking patients about their history of medication use prior to surgery.
  • If patients are using any pholcodine-containing medicine and they have concerns or questions, they should ask a pharmacist or doctor for advice and consult them if symptoms persist.
  • As with all medicines, it is important to always read the label carefully and strictly follow all the directions.

 

References:
1. Julia Medew. 'Cough syrup link to toxic shock during surgery'. The Age, 4 May 2013.
2. Therapeutic Goods Administration (TGA). Response on file.
3. European Medicines Agency (2012). Assessment report for Pholcodine containing medicinal products. EMEA/H/A-31/1292. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pholcodine_31/WC500124716.pdf [last accessed 6 May 2013]
4. Annex II. Scientific conclusions and ground for the mountainous of the marketing authorisations presented by the EMA. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pholcodine_31/WC500124714.pdf [last accessed 6 May 2013]
5. European Medicines Agency (2012) Questions and answers on the review of the marketing authorisations for medicines containing pholcodine: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended. EMA/890819/2011 rev.1. EMEA/H/A-31/1292