Use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline

This document gives recommendation on the use of pleuromutulins in food producing and companion animals in the EU. It discusses their effect on the development of resistance to this class of antimicrobial agents in bacterial species that are of importance for human and animal health, and the potential impact on animal and human health.

Keywords: Pleuromutilins, resistance in bacteria, tiamulin, antimicrobial resistance

Current effective version

Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health (Rev.1)

AdoptedReference Number: EMA/CVMP/AWP/119489/2012 Rev.1Summary:

Pleuromutilins (tiamulin and valnemulin) are used predominately in pigs but to some extent also in poultry and rabbits. It is an essential group of antimicrobial agents in veterinary medicine especially as it is the sole treatment option for enteritis in pigs caused by isolates of Brachyspira hyodysenteriae (swine dysentery) resistant to lincosamides and macrolides. The negative consequences in case such a pathogen were to become pleuromutilin resistant would thus be considerable both from an economic and an animal welfare perspective.

Document history - Revision 1

Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health (Rev.1)

AdoptedReference Number: EMA/CVMP/AWP/119489/2012 Rev.1Summary:

Pleuromutilins (tiamulin and valnemulin) are used predominately in pigs but to some extent also in poultry and rabbits. It is an essential group of antimicrobial agents in veterinary medicine especially as it is the sole treatment option for enteritis in pigs caused by isolates of Brachyspira hyodysenteriae (swine dysentery) resistant to lincosamides and macrolides. The negative consequences in case such a pathogen were to become pleuromutilin resistant would thus be considerable both from an economic and an animal welfare perspective.

Overview of comments received on 'Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health'

Reference Number: EMA/CVMP/AWP/257904/2013 Rev. 1

Document history - First version

Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health

AdoptedReference Number: EMA/CVMP/AWP/119489/2012Summary:

Pleuromutilins (tiamulin and valnemulin) are used predominately in pigs but to some extent also in poultry and rabbits. It is an essential group of antimicrobial agents in veterinary medicine especially as it is the sole treatment option for enteritis in pigs caused by isolates of Brachyspira hyodysenteriae (swine dysentery) resistant to lincosamides and macrolides.

Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health

Draft: consultation closedConsultation dates: 17/12/2012 to 30/06/2013Reference Number: EMA/CVMP/SAGAM/119489/2012Summary:

Pleuromutilins are active against Gram-positive bacteria such as streptococci and staphylococci, anaerobic bacteria and Mycoplasmata. They have been used for decades in veterinary medicine for the control of respiratory and intestinal infections in different animal species, especially in pigs and to a lesser extent in poultry and rabbits. The objective of this reflection paper is to summarise current knowledge on resistance development and the potential impact of this resistance on animal and human health.

Concept paper on Use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health

Draft: consultation closedConsultation dates: 13/10/2011 to 31/01/2012Reference Number: EMA/CVMP/SAGAM/435644/2011