Paediatric safety of azithromycin: worldwide experience

Adverse events and laboratory abnormalities were monitored over 35 days after the commencement of treatment in 45 open studies conducted in Europe, South America, Africa and Asia. These studies were to assess the clinical efficacies of azithromycin and comparator antimicrobial agents in the treatment of paediatric acute bacterial infections. Children (6 months-16 years of age) had been treated with an oral suspension of azithromycin (10 mg/kg given once daily for 3 consecutive days) or with the approved oral dosing regimen of the comparator (amoxycillin, co-amoxiclav, cefixime, cefaclor, clarithromycin, erythromycin, penicillin V, cloxacillin, or roxithromycin). Adverse events were recorded in 232/2655 (8.7%) children treated with azithromycin and in 180/1844 (9.8%) who received comparator treatment. The majority of the treatment-related adverse events were classed as being of only mild or moderate severity and were gastrointestinal: 140 (5.3%) in azithromycin- and 120 (6.5%) in comparator-treated children. Co-amoxiclav was responsible for proportionately more of such events than any other agent. Treatment was discontinued prematurely due to an adverse event in 34 (1.3%) azithromycin- and in 31 (1.7%) comparator-treated children. Incidences of clinically significant laboratory abnormalities were low and occurred with comparable frequency in both treatment groups. The present analysis confirms that azithromycin can be safely used to treat bacterial infections in children of all ages.