EMA Changes Azithromycin Use to Combat Antibiotic Resistance
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended several changes to the way the antibiotic azithromycin is used in the EU, including the removal of certain indications.
The recommendations aim to optimize the use of the antibiotic and minimize the development of antimicrobial resistance, CHMP said.
CHMP's review and re-evaluation of the benefits and risks of azithromycin medicines given by mouth or IV infusion came at the request of the German Federal Institute for Drugs and Medical Devices. It has led to new changes that include uses of the drug to be refined and harmonized, uses to be discontinued, and a new product warning.
The full list of revised uses, found in the published product information, mainly concern upper and lower respiratory tract infections, sexually transmitted diseases, female reproductive system infections, dental infections, and treatment and prevention of types of Mycobacterium avium complex infections in people living with HIV-1.
CHMP said that the antibiotic could no longer be used in moderate acne vulgaris, eradication of Helicobacter pylori, and prevention of exacerbations of eosinophilic and noneosinophilic asthma. This is because its effectiveness in these conditions has not been clearly demonstrated, including that its benefits do not outweigh its risks. These indications will be removed from the product information.
The committee pointed out that some azithromycin medicines are also approved in the EU for topical use, but that these medicines are out of the scope of the review procedure.
Higher Risk for Resistance
Azithromycin is included in the World Health Organization (WHO) list of essential medicines but is also classified by the WHO as an antibiotic that carries a higher risk for antimicrobial resistance. It is included in WHO's Watch category (AWaRe classification), so the drug should be prioritized as a key target for prudent use and monitoring.
CHMP said that there had been an increased use of azithromycin in recent years. A study commissioned by the EMA and performed by DARWIN EU, which analyzed the prescription of the 141 antibiotics in WHO's Watch category between 2012 and 2021 in France, Germany, Spain, the Netherlands, and United Kingdom, found that azithromycin was among the top five most prescribed antibiotics in the majority of databases assessed, and within the top 10 in all the databases included.
Data from the ATLAS and SENTRY databases showed an increasing global prevalence of azithromycin resistance among bacterial strains linked to the approved indications of azithromycin in the EU/European Economic Area.
Research has also shown that azithromycin resistance has increased in recent years. A study published last month (April 2025) in Frontiers in Microbiology found that the prevalence of azithromycin resistance in pathogenic bacteria from clinical samples was 22%, and indicated an increase in prevalence after the COVID-19 pandemic, which the study's researchers described as 'a major concern.'
CHMP explained that a new warning will also be included in the summary of product characteristics about the importance of clinicians assessing the benefits and the risks, considering the local prevalence of resistance, and deciding when preferred treatment regimens are not indicated. This is based on the fact that azithromycin could favor the development of resistance due to its long-lasting, decreasing levels in plasma and tissues after the end of treatment.
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