Paediatric safety of azithromycin: worldwide experience
1International Pharmaceuticals Group, Pfizer Inc., New York, USA.
Insights
Azithromycin is a safe and effective antibiotic for treating bacterial infections in children. This study found it had a similar safety profile to other common antibiotics, with mostly mild gastrointestinal side effects.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
- Antimicrobial Therapy
Background:
- Paediatric acute bacterial infections require effective and safe treatment options.
- Azithromycin is a widely used antibiotic, but its safety profile in children compared to other agents needs continuous evaluation.
Purpose of the Study:
- To assess the safety and tolerability of azithromycin compared to various comparator antimicrobial agents in paediatric patients.
- To monitor adverse events and laboratory abnormalities in children treated for acute bacterial infections.
Main Methods:
- A meta-analysis of 45 open studies conducted globally, involving children aged 6 months to 16 years.
- Children received oral azithromycin (10 mg/kg once daily for 3 days) or comparator antibiotics.
- Adverse events and laboratory abnormalities were monitored for 35 days post-treatment.
Main Results:
- Overall adverse event rates were similar between azithromycin (8.7%) and comparator treatments (9.8%).
- Most adverse events were mild to moderate gastrointestinal issues, with co-amoxiclav showing a higher proportion.
- Treatment discontinuation due to adverse events was low and comparable across groups (1.3% azithromycin vs. 1.7% comparator).
Conclusions:
- Azithromycin demonstrates a favorable safety profile for treating paediatric bacterial infections.
- It is well-tolerated in children, with a low incidence of serious adverse events and laboratory abnormalities.
- Azithromycin is a safe therapeutic option for children across a wide age range.
Abstract:
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.
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