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AgVetLink: Number 62, June 2007

Aminoglycoside review

In response to the recommendations from the report of the Antimicrobial Resistance Expert Panel (30 August 2005) and the advice of the Antimicrobial Resistance Steering Group, NZFSA has agreed with the recommendations and is commencing a review of veterinary medicines containing antimicrobials in the aminoglycoside class.

Recommendations

The recommendations of the Expert Panel and the Steering Group concluded that for products containing aminoglycoside antibiotics the following should apply:

• Evidence of synergistic effect and enhanced efficacy of mixtures of β lactam and aminoglycoside should be required at the time of their next registration.

• Oral aminoglycosides, alone or in combinations, should not be used to treat non-specific enteric infections in groups of food-producing animals. If used to treat gut infections, their selection should be confirmed by bacteriology and susceptibility testing.

Review

The aim of the review is to:

• pinpoint the products in the groups identified by the Expert Panel

• ensure there is adequate supporting evidence to justify their continued use in terms of synergistic effect and enhanced efficacy of mixtures of β lactam and aminoglycoside antimicrobials

• ensure oral amingoglycosides are not marketed for use to treat non-specific enteric infections in groups of food-producing animals.

There are good animal health and welfare reasons to retain injectable and topical aminoglycosides as prescription veterinary medicines. However, injectable combinations of aminoglycosides with β lactam antimicrobials are to be included in this review. Topical preparations for use on skin, eyes or ears are not included.

Reassessment

Following initial consultation with affected registrants, a time frame has now been set for a formal reassessment of relevant products. The reassessment will commence on 1 July 2009. It is expected this time frame will allow applicants to bring their products in line with the recommendations prior to the commencement of the review.

Once the review commences there will be no time extensions given and any products that do not satisfy the Expert Panel's recommendations will have their registrations discontinued. Applicants are strongly advised to submit applications well before the review commences to allow plenty of time to bring their products into conformance.

Any requests for further information on the review and reassessment should be directed to Lucy Johnston, Advisor (ACVM Standards-Animals). Email: lucy.johnston@nzfsa.govt.nz