EMA starts review of azithromycin-containing medicines

EMA’s human medicines committee (CHMP) has started a review of systemic medicines (given by mouth or by injection) that contain the antibiotic azithromycin. Antimicrobial resistance (AMR) against azithromycin is increasing in the European Union (EU). Therefore, and in view of the broad use of these medicines, a re-evaluation of the benefits and risks of azithromycin in its many authorised uses is considered warranted to optimise its use and minimise the risk of AMR development. 

Many azithromycin-containing medicines have been in use for decades and were authorised by national procedures in the EU. This has led to large differences in the product information regarding the indications, treatment dose and duration, and relevant safety information. These differences may conflict with rational use of antibiotics and antibiotic stewardship and may result in further development of antimicrobial resistance to azithromycin. 

EMA will now review all available information on the benefits and risks of azithromycin and will consider whether any changes are required to its approved uses across EU Member States.