The European Medicines Agency (EMA) recently announced significant changes involving updated drug indications for one of the most commonly used antibiotics: azithromycin. The Committee for Medicinal Products for Human Use (CHMP) decided to revise, harmonise, and remove several previously approved indications across the EU. As a result, this decision targets one of the most pressing global concerns: antimicrobial resistance.

Why Updated Drug Indications Matter in Pharmacovigilance

For pharmacovigilance specialists, updated drug indications are more than a regulatory update – they signal changes in prescribing practices and risk assessment. EMA’s decision is based on multiple concerns:

Widespread use of azithromycin among both adults and children;

Resistance patterns recorded in global databases like ATLAS and SENTRY;

WHO’s inclusion of azithromycin in the “Watch” category of its AWaRe classification recommends cautious use.

These findings reinforce the importance of pharmacovigilance in monitoring adverse events, indication creep, and off-label use.

Which Indications Did Regulators Decide to Review?

Following the CHMP’s recommendations, most systemic forms of azithromycin – both oral and IV – are now affected by the updated indications. Key updates include:

• More precise indications aligned with modern clinical guidelines
• Harmonised posology and safety data – including drug interactions, pregnancy use, and side effects
• Consistent updates across all EU product information under a unified regulatory standard

Retained Indications

Azithromycin will remain approved for the treatment of:

• Respiratory tract infections
• Sexually transmitted infections (STIs)
• Pelvic inflammatory disease
• Certain dental infections
• Mycobacterium avium complex in HIV-positive patients

What Indications Are Being Removed?

The CHMP has decided to remove three indications for oral azithromycin due to a lack of sufficient evidence of efficacy outweighing potential risks, especially in terms of resistance:

• Moderate acne (acne vulgaris)
• Helicobacter pylori eradication
• Prevention of asthma exacerbations (both eosinophilic and non-eosinophilic)

New Warning on Resistance

The updated product information will now include a new warning: azithromycin contributes to resistance development because it remains in tissues long after treatment. Therefore, healthcare professionals should carefully evaluate its use – especially in regions with high local resistance – and prescribe it only when no better alternatives exist.

What Pharmacovigilance Professionals Must Know About Updated Drug Indications

In light of these changes, pharmacovigilance professionals should pay close attention to the following points:

• New drug indications redefine how azithromycin should be used, guiding better monitoring and reporting of its safety.
• The focus shifts to rational antibiotic use, helping prevent unnecessary or inappropriate prescriptions.
• Updated product information becomes a vital tool for assessing adverse reactions and tracking how the drug is used.
• Clear communication with healthcare providers and patients is crucial to promote safe, informed use.
• Safety monitoring systems must adapt to the revised indications to accurately identify and analyse adverse event patterns and real-world usage.

Conclusion

EMA’s decision is more than a simple update – it’s a paradigm shift. By narrowing the scope of azithromycin use, the agency emphasises precision, evidence-based therapy, and responsible antibiotic stewardship. Consequently, the updated drug indications provide a powerful example of how regulatory action supports pharmacovigilance and patient safety.

Azithromycin may be the first, but it won’t be the last. Other broad-spectrum antibiotics on WHO’s Watch list could face similar reviews. For those in pharmacovigilance, this call is to stay informed, vigilant, and ready to adapt.