Vol.53 No.6 June 2005
Post marketing Surveillance of Azithromycin in pediatric patients
Medical Affairs, Pfizer Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, Japan
Abstract
Azithromycin (AZM: Zithromac®), a 15-membered ring maclolide antibiotic, was approved in March 2000 and launched in June 2000 in Japan. A special investigation of Zithromac® (in pediatric patients) was started in August 2001 to collect and confirm proper use information, including safety and efficacy in pediatric patients. Of 778 patients, 718 were analyzed for safety and 631 for efficacy.
Of the 718 in the safety analysis, 39 cases of adverse drug reactions (ADRs) were reported in 38 patients, with an ADR incidence of 5.29% (38/718). The commonest ADRs were diarrhea (19 cases) and vomiting (7 cases). No cases of serious ADR were seen.
The incidence of gastrointestinal disorders in patients under 2 years of age, pinpointed in Precautions on the package insert, was 8.57% (12/140). In all cases, seriousness was slight and the outcome of relief or resolution/recovery confirmed.
The incidence of decreased WBC count and decreased neutrophil count also pinpointed in Precautions on the package insert was 0.68% (3/442) and 0.53% (2/376).
Efficacy was 88.8% (523/589) for respiratory tract infection (laryngopharyngitis, acute bronchitis, tonsillitis and pneumonia) and 85.7% (36/42) for otolaryngology tract infections (otitis media), respectively.
The causative organism was identified only in 226, including those with multiple causative organisms, among those included in efficacy analysis in respiratory tract infection. Efficacy for commonest causative organisms was 93.1% (122/131) for Mycoplasma spp., 84.6% (11/13) for Streptococcus pneumoniae, and 77.1% (27/35) for Haemophilus influenzae.
Key word
azithromycin, postmarketing surveillance, pediatric, safety, efficacy
Received
March 2, 2005
Accepted
April 22, 2005
Jpn. J. Chemother. 53 (6): 371-383, 2005
