Postmarketing surveillance on side-effects of cefminox sodium (Meicelin).
A postmarketing surveillance of cefminox sodium (Meicelin, CMNX) for intravenous injection was conducted for about 4 years from August 1987 through June 1991, and 13,431 patients were followed up to evaluate the safety of the drug. The incidence of side-effects was 1.76%. By organ, the most frequently observed were hepatic and of the bile duct system (0.87%) followed by those on leukocytes and reticuloendothelial system (0.24%), skin and adnexa (0.24%) and digestive tract (0.16%) indicating a tendency similar to that of other injectable cephalosporins. The 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 that for patients 16 years old or older (1.90%). Potential side-effects on pregnant women (n = 101) and their babies were also checked. No side-effects occurred among the 52 pregnant women evaluated and no abnormalities were detected in their babies who were followed up for up to 4 years. Cefminox is thus considered to be a highly safe cephalosporin antibiotic.
Mayama
T
T
Pharmaceutical Information and Regulatory Affairs, Meiji Seika Kaisha, Ltd., Tokyo, Japan.
Koyama
Y
Y
Sebata
K
K
Tanaka
Y
Y
Shirai
S
S
Sakai
H
H
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001659:Biliary Tract / Q000187:drug effects; D002513:Cephamycins / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003625:Data Collection; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008099:Liver / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D011247:Pregnancy; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies
D002513:Cephamycins; C046079:cefminox