Recommendations for use of aminoglycosides in animals to reduce risk of antimicrobial resistance

EMA invites comments on a draft reflection paper by 31 October 2017

The European Medicines Agency (EMA) has launched a public consultation on its new “Reflection paper on use of aminoglycosides in animals in the European Union (EU): development of resistance and impact on human and animal health”. The deadline to submit comments is 31 October 2017. Comments should be provided using this form to be sent to vet-guidelines@ema.europa.eu

Aminoglycosides are a class of antimicrobial medicines used in both people and animals to treat a broad spectrum of infections. Main uses in humans include treatment of enterococcal/streptococcal endocarditis and infections caused by multi-drug resistant Gram-negative bacteria. The World Health Organization has classified aminoglycosides as critically important for human health.

They also play an important role in veterinary medicine, where they account for 3.5% of the sales of veterinary antimicrobials in the EU and are used in both food-producing and companion animals. The extensive use of these medicines seems to have resulted in increased development of resistance in various bacterial species.

The purpose of the reflection paper, which was developed by EMA's Antimicrobials Working Party, and adopted by the Committee for Medicinal Products for Veterinary Use (CVMP), is to critically review the current knowledge on the usage of aminoglycosides, the development of resistance and the potential impact of this resistance on animal and human health. On this basis, the paper makes recommendations on how these medicines should be used in animals to maintain their effectiveness to treat infections in both humans and animals.

Although of increasing importance in human medicine to treat multi-drug resistant infections, aminoglycosides are rarely the only treatment option in either veterinary or human medicine and are used in lower numbers of human patients, when compared to other classes of antibiotics such as fluoroquinolones or third- and fourth-generation cephalosporins. The reflection paper proposes to categorise these medicines so that their use in animals would be subject to relevant restrictions.