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


METHODS
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).


CONCLUSIONS
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.
The Department of Internal Medicine V, Aarhus University Hospital, 8000 Aarhus C, Denmark.
H T
HT
Sorensen
G L
GL
Nielsen
C
C
Olesen
H
H
Larsen
F H
FH
Steffensen
H C
HC
Schønheyder
J
J
Olsen
A E
AE
Czeizel
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000009:adverse effects*; D003718:Denmark / Q000453:epidemiology; D005260:Female; D015725:Fluconazole / Q000009:adverse effects*; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D008498:Medical Record Linkage; D011153:Population; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology; D012042:Registries; D012306:Risk
D000935:Antifungal Agents; D015725:Fluconazole