Risk of malformations and other outcomes in children exposed to fluconazole in utero

• Published in: British journal of clinical pharmacology Vol. 48; no. 2; pp. 234 - 238
• Main Authors: Sørensen, Henrik Toft, Nielsen, Gunnar Lauge, Olesen, Charlotte, Larsen, Helle, Steffensen, Flemming Hald, Schønheyder, Henrik C., Olsen, Jørn, Czeizel, Andrew E.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01.08.1999; Blackwell Science; Blackwell Science Inc
• Subjects: Abnormalities, Drug-Induced - epidemiology; Adolescent; Adult; Antifungal Agents - adverse effects; Biological and medical sciences; Denmark - epidemiology; Drug toxicity and drugs side effects treatment; Female; fluconazole; Fluconazole - adverse effects; Follow-Up Studies; Humans; Infant, Newborn; malformations; Medical Record Linkage; Medical sciences; Miscellaneous (drug allergy, mutagens, teratogens...); Pharmacoepidemiology; Pharmacology. Drug treatments; Population; Pregnancy; Pregnancy Outcome - epidemiology; Registries; Risk; safety; Denmark; Human; Pregnancy disorders; Fluconazole; Toxicity; Low birth weight; Teratology; Congenital disease; Pregnancy; Newborn diseases; Antifungal agent; Prematurity; Malformation; Cohort study; Triazole derivatives
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1046/j.1365-2125.1999.00989.x

Aim  Fluconazole is an active drug systematically used in the oral treatment of vaginal candidiasis and other fungal diseases. We examined the risk of malformations and other birth outcomes following pregnancy related exposures. Method  From 1 January 1991 to 31 December 1996 we identified 165 women who had taken fluconazole just before or during pregnancy in the Pregnancy Outcome Section of the North Jutland Pharmacoepidemiological Prescription Database, Denmark, which is linked to the Danish Medical Birth Registry. We compared their birth outcomes (malformation, low birth weight and preterm delivery) with the outcomes among 13 327 women who did not receive any prescriptions during their pregnancies. Results  The prevalence of malformation was 3.3% (four cases) among the 121 women, who had used fluconazole in the first trimester, and 5.2% (697 cases) in offspring to controls (odds ratio: 0.65, 95% confidence limits: 0.24–1.77). Furthermore, we did not find any significantly elevated risk of preterm delivery (odds ratio: 1.17, 95% confidence limits: 0.63–2.17) and low birth weight (odds ratio: 1.19, 95% confidence limits: 0.37–3.79). Conclusion  The study showed no increased risk of congenital malformations, low birth weight or preterm birth in offspring to women who had used single dose fluconazole before conception or during pregnancy.