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Relative Risk of Vaginal Candidiasis After Use of Antibiotics Compared with Antidepressants in Women

Postmarketing Surveillance Data in England


Background: Vaginal candidiasis is a common infection in women. The microflora of the vagina are influenced by a number of factors, including pregnancy, oral contraceptive use, menses and diabetes mellitus. Previous antibiotic use is generally accepted to be a risk factor for vaginal candidiasis but the published evidence to support this is limited.

Aim: To determine the relative risk of vaginal candidiasis following the use of antibiotics compared with antidepressants in prescription-event monitoring (PEM) studies.

Methods: Using data from postmarketing surveillance studies of six antibiotics and six antidepressants, conducted using the observational cohort technique of PEM, the number of reports of vaginal candidiasis was determined in women aged ≥16 years, in each of the first 7 weeks following a prescription for one of these drugs. The relative risks for vaginal candidiasis following the use of these antibiotics and for each of the individual antibiotics compared with antidepressants were calculated for each week and for the overall 7-week period. Women treated with antidepressants were the most suitable comparator group from the PEM database, as they were of a similar age range and the studies were conducted at a similar time period to those of the antibiotics. Also, there was no pharmacological plausibility for vaginal candidiasis being associated with antidepressants.

Results: There were 188 reports of vaginal candidiasis in 31 588 women, aged ≥16 years, treated with antibiotics and 70 in the 45 492 treated with antidepressants. The relative risk for vaginal candidiasis (antibiotic/antidepressants), was highest in the second week, 10.70 (95% CI 4.86–23.55) but was also significantly greater in the first and third weeks after the start of treatment. The risk was also higher in each of the 3 weeks after starting the course for five of the antibiotics, compared individually to the group treated with antidepressants, the exception being fosfomycin, which had a much smaller cohort.

Conclusion: This study shows a significant increase in the risk of developing vaginal candidiasis following the use of the antibiotics studied (ciprofloxacin, ofloxacin, norfloxacin, cefixime, azithromycin and fosfomycin) compared with that after taking the antidepressants fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine and nefazodine in these PEM studies.

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We would like to record our keen appreciation of the cooperation of the general practitioners and numerous other colleagues who have helped in this investigation. We would particularly like to thank Professor R.D. Mann the previous director of the Drug Safety Research Unit (DSRU) for his initial contribution to this work. In addition we wish to thank Mrs Lesley Flowers for the preparation of this manuscript. We would also like to thank the UK Prescription Pricing Authority for their important participation.

The DSRU is a registered medical charity. It receives unconditional donations from a number of pharmaceutical companies. These companies have no say in the conduct of the studies and have no statistical or editorial control over the analysis or reporting of results. The DSRU has received unconditional donations from some of the manufacturers of these medications but no support was provided for this study. Dr Shakir has received from the pharmaceutical industry lecturing and consultancy fees as well as support to attend scientific meetings unrelated to this study. Dr Wilton has received support from the pharmaceutical industry to attend scientific meetings unrelated to this study.

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Correspondence to Lynda V. Wilton.

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Wilton, L.V., Kollarova, M., Heeley, E. et al. Relative Risk of Vaginal Candidiasis After Use of Antibiotics Compared with Antidepressants in Women. Drug-Safety 26, 589–597 (2003).

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