EMA Recommends Major Changes to Azithromycin Use to Tackle Antibiotic Resistance

The European Medicines Agency (EMA) has announced significant changes to the approved uses of azithromycin, a widely prescribed antibiotic, in a move aimed at curbing the growing threat of antimicrobial resistance across the European Union.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) conducted a comprehensive review of azithromycin’s benefits and risks, prompted by rising concerns over increased use and mounting evidence of resistance among key bacterial pathogens. Azithromycin, long recognized as an essential medicine by the World Health Organization (WHO), has recently been classified by the WHO as carrying a higher risk for resistance and is included in the agency’s Watch category, which calls for stricter monitoring and more prudent use.

Key Changes to Azithromycin Use

• Refined and Harmonized Indications: The CHMP has updated and clarified the conditions for which azithromycin can be prescribed. The revised indications primarily include:

  • Upper and lower respiratory tract infections (such as acute bacterial sinusitis, streptococcal tonsillitis, pharyngitis, chronic bronchitis exacerbations, and community-acquired pneumonia)

  • Sexually transmitted diseases (including urethritis and cervicitis caused by Chlamydia trachomatis or Neisseria gonorrhoeae)

  • Infections of the female reproductive system (such as pelvic inflammatory disease)

  • Dental infections (like periodontal abscesses and periodontitis)

  • Treatment and prevention of certain Mycobacterium avium complex infections in people living with HIV-1

• Discontinued Uses: Azithromycin can no longer be prescribed for:

  • Moderate acne vulgaris

  • Eradication of Helicobacter pylori (a bacterium that can cause stomach ulcers)

  • Prevention of exacerbations in both eosinophilic and non-eosinophilic asthma

  The CHMP determined that the effectiveness of azithromycin in these conditions had not been clearly demonstrated, and the risks outweighed the potential benefits. These indications will be removed from product information.

• New Product Warning: Updated product information will now include a warning about the risk of antimicrobial resistance, emphasizing the need for healthcare professionals to weigh the benefits and risks, especially considering local resistance patterns and when alternative treatments are available.

Background and Rationale

Recent data, including findings from a large EMA-commissioned study (DARWIN EU), revealed that azithromycin remains among the most frequently prescribed antibiotics in Europe, despite recommendations for more cautious use. The increased consumption has been linked to a rise in resistant bacterial strains, threatening the long-term effectiveness of this critical antibiotic.

The CHMP’s review incorporated clinical study results, resistance data, and current treatment guidelines to ensure that azithromycin’s use is evidence-based and aligned across all EU member states. The committee’s recommendations now await a final, legally binding decision from the European Commission.

Advice for Patients and Healthcare Providers

Patients currently prescribed azithromycin are advised not to stop their medication without consulting their doctor or pharmacist. Healthcare professionals are encouraged to familiarize themselves with the updated prescribing information and to consider local resistance trends when selecting antibiotics.

Disclaimer:
This article is for informational purposes only and is based on official communications from the European Medicines Agency and related sources. It is not a substitute for professional medical advice, diagnosis, or treatment. Patients should consult their healthcare providers regarding any questions about their medications or treatment plans6.