A Population-Based Case-Control Teratological Study of Furosemide Treatment during Pregnancy

ISSN： 1173-2563

Source： Clinical Drug Investigation, Vol.18, Iss.4, 1999-10, pp. : 307-315

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Abstract

Objective: To study the human teratogenic potential of furosemide (frusemide) treatment during pregnancy.Design and Setting: This study used pair analysis of newborn infants with congenital abnormalities and matched healthy controls. Cases and controls were from the large population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA), 1980 to 1996. Information on maternal drug exposure was obtained from the parents by means of questionnaires, antenatal care logbooks and interviews.Study Participants: Women who had babies without any defects (population control group) and women who had offspring with congenital abnormalities.Main Outcome Measures: Congenital abnormalities diagnosed during the second and third trimester and postnatally from birth until the age of 1 year.Results: Of 38 151 population controls, 450 (1.2%) had mothers who were exposed to furosemide treatment during pregnancy; the corresponding figures for cases were 22 865 and 246 (1.1%). The odds ratio was 0.9 (95% confidence interval 0.8 to 1.1). The distribution of congenital abnormalities in infants born to all furosemide recipients did not differ significantly from the expected distribution on the basis of baseline rates in the HCCSCA. Analysis of the extent of medically documented furosemide treatment during the second and third months of gestation, i.e. in the critical period for most major congenital abnormalities, did not indicate a teratogenic potential of furosemide, either by comparing the total control group with different congenital abnormality groups or by case-matched control pair analysis.Conclusion: Maternal exposure to furosemide during pregnancy does not present a detectable teratogenic risk to the fetus; however, the number of pregnant women who were treated with furosemide in the critical period of most major congenital abnormalities was limited (15 controls vs 14 cases).