SAFETY OF FLUCONAZOLE IN THE TREATMENT OF VAGINAL CANDIDIASIS - A PRESCRIPTION-EVENT MONITORING STUDY, WITH SPECIAL REFERENCE TO THE OUTCOME OF PREGNANCY

A prescription-event monitoring (PEM) study has confirmed that flucona zole, a bis-triazole oral antifungal drug, is a safe and effective tre atment for vaginal candidiasis. Useful information was available on 15 ,015 questionnaires returned by general practitioners. The events were compared with those recorded in PEM studies of itraconazole and 31 ot her drugs in a total of more than 330,000 patients. The frequency of e vents in the study of itraconazole was almost identical. Upper respira tory tract and genitourinary infections were reported with above-avera ge frequency but the relationship was with the disease being treated r ather than the drug itself. No serious adverse effects were recorded w ith an unacceptably high incidence. None of the 125 deaths was caused by fluconazole. Although contraindicated for vaginal candidiasis in pr egnancy, fluconazole was taken by 289 women at some time during the mo nths before or during pregnancy; a followup study by questionnaire of the outcome of pregnancy showed fluconazole to be without harmful effe ct. It is concluded that fluconazole is a well tolerated drug in the t reatment of vaginal candidiasis and is associated with very few advers e effects.