With the rising risk of antibiotics resistance, EMA’s human medicines committee (CHMP) has decided on readjusting the use of some antibiotics like azithromycin and limiting its indications, in order to minimize the risk of antibiotic resistance.
For years now azithromycin has been used for treatment of various infections, which by time has led to increased risk of it becoming antimicrobial resistant. To support more evidence-based use and help preserve the effectiveness of this antibiotic, the CHMP re-assessed the benefit-risk profile of oral and intravenous azithromycin for its approved indications.
The committee evaluated comprehensive data, including clinical trial results, resistance patterns of relevant pathogens in the EU, the likelihood of resistance developing during treatment, and current national and European treatment guideline recommendations.
The CHMP recommended updating most approved uses of oral and IV azithromycin. The goal is to reflect the latest evidence, make indications more specific, and ensure consistency in dosing, contraindications, drug interactions, use during pregnancy, side effects, and clinical data across all products.
The updated indications mainly include:
- Respiratory tract infections (e.g., sinusitis, tonsillitis, pharyngitis, bronchitis flare-ups, pneumonia)
- Sexually transmitted infections (e.g., chlamydia and gonorrhea-related urethritis and cervicitis)
- Female reproductive system infections (e.g., pelvic inflammatory disease)
- Dental infections (e.g., abscesses and periodontitis)
- Treatment and prevention of Mycobacterium avium complex in HIV-1 patients
Moreover, CHMP recommended discontinuing the use of oral azithromycin for moderate acne, Helicobacter pylori eradication, and prevention of asthma exacerbations, citing insufficient evidence of benefits outweighing risks.
Lastly, a new warning will be added to highlight the risk of antimicrobial resistance due to prolonged drug levels after treatment. Azithromycin should only be prescribed after careful benefit-risk assessment, considering local resistance patterns and when alternative treatments are unsuitable.
Learn more: Changes to the use of antibiotic azithromycin | European Medicines Agency (EMA)
