[Postmarketing survey on the clinical use of cefotiam].
We performed a survey of clinical experience of cefotiam (CTM: Pansporin) as postmarketing surveillance (PMS), and evaluated the efficacy and safety of CTM in 10,499 cases of data which were collected during the first 2 years after approval. The following results were obtained. The efficacy rate of CTM in the treatment of various infections was 83.2%, which was equal or superior to the clinical results obtained before approval. A total of 472 adverse drug reactions was reported by 10,499 patients (4.50%). The commonest adverse drug reactions was liver function abnormality (230 cases), followed by dermal symptoms (103 cases), gastrointestinal symptoms (53 cases) and renal function abnormality (20 cases) in the order mentioned. All of these adverse drug reactions had already been known for cephem antibiotics, and no remarkable adverse drug reactions specific to CTM was found. The above PMS results indicate the same efficacy of CTM that obtained from premarketing studies. As regards safety, there was no remarkable unexpected adverse drug reaction and their profile was also the same as that found in premarketing studies. Thus, the utility of CTM was confirmed.
D000293:Adolescent; D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000188:drug therapy*; D002439:Cefotaxime / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015310:Cefotiam; D056486:Chemical and Drug Induced Liver Injury; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004342:Drug Hypersensitivity / Q000276:immunology; D005069:Evaluation Studies as Topic; D005260:Female; D006403:Hematologic Tests; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007674:Kidney Diseases / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009497:Neurotic Disorders / Q000139:chemically induced; D011358:Product Surveillance, Postmarketing; D012867:Skin / Q000187:drug effects; D012882:Skin Tests
D015310:Cefotiam; D002439:Cefotaxime