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PEM report number 4. Ciprofloxacin
Author(s) -
Inman William,
Kubota Kiyoshi,
Pearce Gillian,
Wilton Lynda
Publication year - 1993
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.2630020407
Subject(s) - medicine , ciprofloxacin , malaise , medical prescription , population , urinary system , diarrhea , pediatrics , adverse effect , depression (economics) , antibiotics , enoxacin , norfloxacin , surgery , environmental health , macroeconomics , microbiology and biotechnology , economics , pharmacology , biology
Abstract The fluoroquinolone antibiotic ciprofloxacin has been studied by Prescription‐Event Monitoring (PEM) in 11,477 patients who had received prescriptions from general practitioners in England between November 1988 and January 1989. There were about 50% more females in the series than males and the average ages were 53.2 and 55.5 years respectively. Chest and urinary infections were the most common indications. Forty‐five per cent of the patients used 500 mg daily and 42% 1000 mg daily. Ciprofloxacin was said to have been effective in 90.3% of patients. The events were compared with those reported in 25 other studies in order to obtain some impression of the background rates in a population of more than a quarter of a million patients monitored by PEM. The events most frequently reported were related to the infections that were being treated and the most common side‐effects were those affecting the gastrointestinal system. There were three definite and one doubtful case of photosensitivy. Among the psychiatric events, only depression and malaise or lassitude occurred at a rate which exceeded one per 1000 patients during the first 13 weeks of follow‐up. Fourteen patients suffered convulsions but only two cases were considered to be possibly related either to treatment or to pyrexia associated with urinary tract infection. No cases of pseudomem‐branous colitis were identified although diarrhoea was the most common gastrointestinal event. Following the withdrawal of temafloxacin, the ciprofloxacin data were searched for evidence of hepatic or renal damage or hypoglycaemia, but no evidence was found with ciprofloxacin, or in, as yet uncompleted, studies of enoxacin, ofloxacin or norfloxacin. No serious adverse reactions (ADRs) or deaths attributable to ciprofloxacin were recorded and no previously unrecognized hazards were identified. The PEM data were compared with selected results from clinical trials. For the most part the incidence of events encountered during a three‐month period resembled those in clinical trials very closely. It was concluded that ciprofloxacin is a safe and effective antibiotic prescribed in general practice.