EU drug regulator decides ongoing antibiotic shortage not a ‘major event’

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Europe’s drug regulator has decided not to label the ongoing shortage of antibiotics in the continent a “major event”, according to a source familiar with the matter.

The declaration of a “major event”, would allow the European Medicines Agency (EMA) to coordinate action at a pan-European level and increase the reporting obligations of manufacturers.

Certain widely-used antibiotics, including amoxicillin used to treat bacterial infections and often prescribed for ear and chest infections in children have been in short supply since October.

Nearly all the countries in Europe are reporting shortages, according to the EMA.

A meeting of the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) took place earlier on Thursday, where the issue was discussed.

On Wednesday, a consortium of patient and consumer groups wrote to the EMA saying not enough was being done to address the ongoing shortages, and that the use of alternative antibiotics was squeezing supplies of these other medicines.

The groups also recommended the EMA declare the situation a ‘major event’.