2018 June - APVMA review of macrolide antibiotics – final decision
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The Australian Pesticides and Veterinary Medicines Authority (APVMA) initiated a review of macrolide antibiotics (kitasomycin, oleandomycin and tylosin) due to concern, raised by the Joint Expert Advisory Committee on Antibiotic Resistance (JETACAR), about the potential risk of transfer of antibiotic resistance to humans following use of macrolides in animals.
Use of antibiotics as growth promotants requires low doses for extended periods creating a highly selective pressure for resistance
The APVMA has decided to withdraw approval for the use of macrolide antibiotics for growth promotion in animal production. This means that registration of the product VET ONLY TRUBIN L-50 GROWTH PROMOTANT FOR PIGS (Registration No. 35806) will be cancelled.
There will also be changes to labels of a number of other products registered for therapeutic use to include the following restraint statement:
Prior to prescribing (Name of Product), investigate the use of non-antibiotic options. If (Name of Product) is indicated and selected for use, prudent prescribing practices (appropriate dose, duration and frequency to minimise treatment failure while minimising the emergency of antimicrobial resistance) must be adhered to.
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL.
There will be a 12-month phase out period. This allows use of TRUBIN L-50 GROWTH PROMOTANT FOR PIGS and other kitasomycin, oleandomycin and tylosin products that do not carry the new labels until 5 April 2019.
A copy of the final report is available from the APVMA website.
Prepared by
Jenene Kidston
Technical Specialist Farm Chemicals
Biosecurity and Food Safety
NSW Department of Primary Industries
Email: jenene.kidston@dpi.nsw.gov.au or phone 02 6391 3625