EMA Proposes Measures to Lower Risks Surrounding Use of Antibiotics in Animals

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The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.


The European Medicine’s Agency announced on Dec. 19, 2014 recommendations to lower the risk of animal-to-human transfer of antimicrobial resistance (AMR) associated with the use of antibiotics in animals. According to a press release, the focus of the recommendations was to promote the responsible use of veterinary antibiotics that are crucial to human medicine.

According to the European Food Safety Authority (EFSA), the European Commission launched a strategy in the EU in 2001 to combat the threat of AMR by phasing out antibiotics for non-medical use in animals.

The new recommendations from EMA include identifying the potential risks to public health at an early stage of authorization for new veterinary antimicrobial substances; monitoring the development of resistance in specific bacteria when a substance is first approved in veterinary medicine; introducing legal tools to restrict the use of antibiotics in animals if a risk to public health is identified; and monitoring changes in animal-based antimicrobials that might impact antibiotics used in human medicine (i.e. fluoroquinolones and cephalosporins).


Off-label use of veterinary medicines was also addressed, with recommendations that included limiting or banning off-label use in animals of certain microbials authorized only in human medicine; prescribers keeping records of off-label use; and authorities collecting data on off-label use of antibiotics used in animals.

Similarly, in December 2013, FDA reported that they would be taking steps to limit the use of “medically important antimicrobials in food animals” to limit the development of AMR in humans. In March 2014, the agency announced that it had received “strong industry commitment” for its proposed strategy to limit antimicrobial use in food animals. The CDC reports that while the use of antibiotics are quite common in animals, there is currently no system to track the actual amount of antibiotics used in food animals (in the US).

Source: EMA