UNITED KINGDOM, London. The European Medicines Agency (EMA) has recommended that colistin-containing medicines should only be used as a second line treatment in animals and that their sales should be minimised across all European Union (EU) Member States to reduce the risk of antimicrobial resistance. The advice updates EMA guidance from 2013 and takes into account comments made by stakeholders during a public consultation.
The European Commission asked for this update in response to the discovery of a new mechanism of resistance in bacteria to colistin (caused by the mcr-1 gene). The gene can be transferred between different types of bacteria, potentially causing a rapid development of resistance. The gene was first identified in bacteria (Enterobacteriaceae) in South China, and since then has also been found in the EU and other regions.
In light of the new evidence, the Antimicrobial Advice Ad Hoc Expert Group (AMEG) had been asked to re-evaluate the impact of the use of colistin on human and animal health, the consequences of resistance and what alternative treatments are available. Moreover, the group was asked to consider adequate risk management measures. The advice was endorsed by both the Committee for Medicinal Products for Veterinary Use (CVMP) and the Committee for Medicinal Products for Human Use (CHMP).
In its advice, AMEG underlined that the reduction of colistin sales should not be compensated by increase in the use of other types of antimicrobials, but should be achieved through other measures such as improved farming conditions, biosecurity between production cycles, and vaccination of livestock.
In addition, colistin should be reclassified and added to Category 2 of the AMEG classification system, which includes medicines reserved for treating infections in animals for which no effective alternative treatments exist. This category includes certain classes of antimicrobials listed by the World Health Organization as critically important to human health. Because of the risk posed to public health by their veterinary use, these medicines are subject to specific restrictions.