HPS Pharmacies wish to give notice that the Therapeutic Goods Administration (TGA) has decided to cancel the registration of all pholcodine-containing medicines in Australia and is recalling them from pharmacies.
Pholcodine is a cough suppressant that can be found in a range of products, particularly cough syrups and lozenges, intended for the treatment of non-productive cough. It is also used in combination with other active ingredients for the management of cold and flu symptoms.
The TGA investigated the safety of pholcodine following a review by the European Medicines Agency (EMA) which recommended the withdrawal of pholcodine-containing products from the market. The EMA review supports a previously suspected link between pholcodine and anaphylactic reactions to neuromuscular blocking agents.
It is worth noting that the evidence supporting the efficacy of pholcodine is limited and therapeutic alternatives are available for managing dry cough.
Please inspect your stock and quarantine all pholcodine-containing products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.
Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies.
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