EMA to Investigate Use of Last-Resort Antibiotic

Regulatory NewsRegulatory News | 11 January 2016 |  By 

The European Medicines Agency (EMA) announced Monday that it will investigate the use of a last-resort antibiotic after the discovery of a gene in the EU that causes bacteria, such as E. coli, to become resistant to the drug.


In November, scientists published a study in The Lancet on the gene, known as MCR-1, which was found to cause bacteria to become resistant to the last-resort antibiotic, known as colistin, which is of the polymyxin class and can be transferred easily between different types of bacteria.

“The emergence of MCR-1 heralds the breach of the last group of antibiotics, polymyxins, by plasmid-mediated resistance…Our findings emphasise the urgent need for coordinated global action in the fight against pan-drug-resistant Gram-negative bacteria,” the researchers wrote.

And while the Lancet study only focused on China, this latest request from the European Commission for EMA to investigate the situation makes clear that the gene has been subsequently found in England and Wales.

As the US National Institute of Allergy and Infectious Diseases notes, colistin was approved for use in the 1950s but health providers stopped using it in the 1970s because of its toxicity, though recently there’s been more use of the cheap drug to treat multidrug-resistant bacteria, particularly in humans.

And worldwide demand for the antibiotic in agriculture has been steadily increasing in recent years, according to Reuters.

EMA Investigation

Now the European Commission is requesting that the EMA investigate the use of colistin and decide if it should revise its 2013 advice on the responsible use of the drug in animals, particularly pigs, because of its important role as a "last defense against antimicrobial-resistant bacteria."

More specifically, the agency will reconvene its Committee for Veterinary Medicinal Products’ (CVMP) Antimicrobial Advice Ad Hoc Expert Group (AMEG), which prepared the 2013 advice.

That group recommended maintaining the use of colistin in veterinary medicine but only for the treatment of infected animals and those in contact with them, and removing all indications for preventive use. The group also called to strengthen the systems for surveillance of antimicrobial resistance to colistin and carry out a new review in case of a substantial increase of colistin resistance in animal bacteria or other new relevant information with a potential impact on public health.

EMA’s update will take into account the importance of colistin to human and veterinary medicine, the impact of resistance, the availability of alternative treatments and the effectiveness of possible risk management measures.

The agency expects to finalize the update over the next six months.



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