The European Medical Association’s human medicines committee (CHMP) has recommended several changes to how the antibiotic azithromycin is used, including the removal of certain indications.
The intention is to to optimise the use of this common antibiotic and minimise the development of antimicrobial resistance.
Azithromycin has been used for decades to treat a wide range of infectious diseases, both in children and adults, and is on the WHO list of essential medicines, which highlights its importance for public health.
However, azithromycin is also classified as an antibiotic that carries a higher risk of antimicrobial resistance and is included in WHO’s Watch category (AWaRe classification). Data show that antimicrobial resistance against this antibiotic has increased in recent years.
While medicines in WHO’s Watch category should be prioritised as key targets for prudent use and monitoring, consumption data indicate an increased use of azithromycin medicines in recent years.
A recent EMA-commissioned study, performed by DARWIN EU showed a broad use of this antibiotic across the EU, both in adults and children.
It has, therefore, re-evaluated the benefits and risks of azithromycin medicines given by mouth or infusion (drip) into a vein for the various authorised uses.
Uses to be amended
Based on its comprehensive review, the CHMP recommended amending most of the authorised uses of azithromycin medicines (by mouth or infusion).
The revisions mainly concern:
* Upper and lower respiratory tract infections (infections of the nose, throat, airways and lungs), such as acute bacterial sinusitis, acute streptococcal tonsillitis and pharyngitis, acute exacerbations of chronic bronchitis and community-acquired pneumonia;
* Sexually transmitted diseases, such as urethritis and cervicitis caused by Chlamydia trachomatis, or Neisseria gonorrhoeae;
* Infections of the female reproductive system, such as pelvic inflammatory disease;
* Dental infections, such as periodontal abscesses and periodontitis;
* Treatment and prevention of types of Mycobacterium avium complex infections in people living with HIV-1 infection.
The full list of revised uses can be found in the published product information – https://www.ema.europa.eu/en/documents/referral/azithromycin-article-31-referral-annex-iii_en.pdf.
Uses to be discontinued
In addition, the Committee recommended discontinuing the use of azithromycin taken by mouth (currently authorised in few Member States) for:
* moderate acne vulgaris;
* eradication of Helicobacter pylori, the bacterium that causes infection in the stomach which can lead to chronic inflammation and ulcer;
* prevention of exacerbations (attack) of eosinophilic and non-eosinophilic asthma.
The Committee considered that the benefits do not outweigh the risks.
New warning
The CHMP also recommended including a warning in the product information to highlight the risk of antimicrobial resistance, warning that azithromycin should only be initiated after a careful assessment of the benefits and the risks, considering the local prevalence of resistance, and when preferred treatment regimens are not indicated.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
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