CONCERNS over antimicrobial resistance have led the European Medicines Agency (EMA) to recommend several changes to the way the antibiotic azithromycin is used in the EU, including the removal of certain indications.
The aim is to optimise the use of this common antibiotic and minimise the development of antimicrobial resistance.
Azithromycin is classified by the World Health Organization (WHO) as an antibiotic that carries a higher risk of antimicrobial resistance and is included in WHO's Watch category (AWaRe classification).
Data shows that use of the antibiotic has increased in the EU in recent years, while antimicrobial resistance against this antibiotic has also increased.
Most of the authorised uses have been amended to make them more precise, with the dosing recommendations, including per age groups, also harmonised.
In addition, the following indications have been removed from product information: moderate acne vulgaris; eradication of Helicobacter pylori; and prevention of exacerbations of eosinophilic and non-eosinophilic asthma.
A new warning will be included in the summary of product characteristics regarding the development of antimicrobial resistance and the need to assess the benefits and the risks, considering the local prevalence of resistance, and when preferred treatment regimens are not indicated.
Sold as Zithromax and generics in Australia, the TGA issued a warning last year about the risk of sudden cardiovascular death, with this information added to the Product Information (PI) and Consumer Medicine Information (CMI) documents.
The above article was sent to subscribers in Pharmacy Daily's issue from 28 May 25
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