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Posted: 31st July 2013

European Medicines Agency gives advice

Recommendations for colistin and tigecycline use

The European Medicines Agency (EMA) has provided advice to the European Commission on the impact of using antibiotics colistin and tigecycline in animals.

While the agency recommended maintaining but restricting the use of colistin in animals, it suggested tigecycline should remain unapproved for such use.

The recommendations were made following questions directed at the EMA by the commission, regarding the use of antimicrobials and their subsequent impact on both human and animal health.

In response to the first of four questions, the agency commented that colistin and tigecycline have become life-saving treatments for different kinds of multidrug-resistant bacteria in humans.

It advised that there is no available evidence that colistin, which has been used in veterinary medicine for more than 50 years, transfers any resistance to man when used in animals.

However, the EMA did recommend that more research and surveillance should be carried out on the subject.

It also recommended "maintaining the use of colistin in veterinary medicine but restricting its use to the treatment of infected animals and those in contact with them" – rather than using it as a preventative.

Meanwhile, the EMA advised that there is no need for tigecycline to be authorised for use in animals at present.

Its recommendation read: "If the need for an approval of tigecycline as a veterinary medicine should ever arise in the future, authorisations should only be considered on the basis of a positive benefit-risk assessment, which would take into account the risk of transfer of resistance to humans."

The EMA has confirmed that the scientific answers to all four of the commission's questions are expected to be finalised by the end of 2014.

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