POSTMARKETING SURVEILLANCE ON SIDE-EFFECTS OF CEFMINOX SODIUM (MEICELIN)

A postmarketing surveillance of cefminox sodium (Meicelin, CMNX) for i ntravenous injection was conducted for about 4 years from August 1987 through June 1991, and 13,431 patients were followed up to evaluate th e safety of the drug. The incidence of side-effects was 1.76%. By orga n, the most frequently observed were hepatic and of the bile duct syst em (0.87%) followed by those on leukocytes and reticuloendothelial sys tem (0.24%), skin and adnexa (0.24%) and digestive tract (0.16%) indic ating a tendency similar to that of other injectable cephalosporins. T he incidence of the side-effects among elderly patients (65 years old or older) was 2.12%, whereas among patients 64 years old or younger it was 1.58% with no significant differences between the two groups. No side-effects specific to the elderly were observed. Among children 15 years old or younger the incidence was 0.59%, which was lower than tha t for patients 16 years old or older (1.90%). Potential side-effects o n pregnant women (n = 101) and their babies were also checked. No side -effects occurred among the 52 pregnant women evaluated and no abnorma lities were detected in their babies who were followed up for up to 4 years. Cefminox is thus considered to be a highly safe cephalosporin a ntibiotic.