An examination of nearly 1 million birth records revealed a 3-fold
increased risk for tetralogy of Fallot among infants whose mothers took
fluconazole in the first trimester, according to a study published in
the August 29 issue of the New England Journal of Medicine.
The study showed no association between the antifungal and 14 other birth defects previously linked to it. However, Ditte Mølgaard-Nielsen, MSc, from the Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark, and colleagues showed that common therapeutic doses of fluconazole in the first trimester resulted in an adjusted odds ratio of 3.16 (95% confidence interval [CI], 1.49 - 6.71) for tetralogy of Fallot. The absolute risk for tetralogy of Fallot remains small, with an estimated 6.5 excess cases per 10,000 infants exposed to the antifungal (95% CI, 1.5 - 17), the authors report.
The study showed no association between the antifungal and 14 other birth defects previously linked to it. However, Ditte Mølgaard-Nielsen, MSc, from the Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark, and colleagues showed that common therapeutic doses of fluconazole in the first trimester resulted in an adjusted odds ratio of 3.16 (95% confidence interval [CI], 1.49 - 6.71) for tetralogy of Fallot. The absolute risk for tetralogy of Fallot remains small, with an estimated 6.5 excess cases per 10,000 infants exposed to the antifungal (95% CI, 1.5 - 17), the authors report.
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