In November 2004, the APVMA released its decision on the review of virginiamycin.
In the final report, the APVMA recommended:
- cancelling the registration and label approvals of three products that had label claims relating to growth promotion, improved feed efficiency or both
- varying the conditions of label approval for the three products (the label claims of which were for the prevention of necrotic enteritis in broiler chickens and lactic acidosis in cattle and sheep) to:
- include a maximum treatment period of 21 days in chickens and 28 days in cattle and sheep, and only one treatment in any 12-month period
- delete all label claims, indications and use patterns that refer to growth promotion, improved feed conversion efficiency or both
- include more specific instructions and restraints pertaining to their use for the prevention of lactic acidosis in sheep and cattle and necrotic enteritis in chickens.
The APVMA decided to vary the labels of Eskalin Feed Premix for Cattle (APVMA 46049), Eskalin Wettable Powder Spray-On Feed Premix (APVMA 49111) and Eskalin 500 Feed Premix (APVMA 51354) by imposing mandatory restrictions on off-label uses, limiting the duration of use of the products to 28 days, and limiting the number of re-treatments of virginiamycin in a 12-month period. In 2005, Phibro Animal Health, the registrant of the three affected products, applied to the Administrative Appeals Tribunal (AAT) for a review of APVMA's decision.
During the AAT proceedings, Phibro Animal Health and the APVMA agreed that virginiamycin could be used prudently. The AAT determined that the label changes set out above would not proceed. Instead, the labels would be varied to require that veterinarians prescribe the three Eskalin products in accordance with the Australian Veterinary Association’s (AVA) Code of Practice for Prescription and Use of Products which Contain Antimicrobial Agents. The code of practice contains specific guidelines for the use of products that contain virginiamycin.
Labels for products that contain virginiamycin now bear the following mandatory prudent use statements:
Prior to prescribing [Name of Product] investigate the use of non-antibiotic options. If virginiamycin is indicated and selected for use, prescription must be consistent with the AVA Code of Practice for Prescription and Use of Products which Contain Antimicrobial Agents. Dosage regimens should be designed for each situation with an appropriate duration and frequency to minimise treatment failure while minimising the emergence of antimicrobial resistance. Review farm records on the use of product containing virginiamycin to ensure compliance with prescribing instructions.
NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL.