Research
Obstetrics
Acetaminophen use during pregnancy: effects on risk for congenital abnormalities

https://doi.org/10.1016/j.ajog.2007.08.040Get rights and content

Objective

We evaluated if acetaminophen, one of the most frequently used drugs among pregnant women is associated with an increased prevalence of congenital abnormalities.

Study Design

We selected 88,142 pregnant women and their liveborn singletons from the Danish National Birth Cohort who had information on acetaminophen use during the first trimester of pregnancy. We used the National Hospital Registry to identify 3784 (4.3%) children from the cohort diagnosed with 5847 congenital abnormalities.

Results

Children exposed to acetaminophen during the first trimester of pregnancy (n = 26,424) did not have an increased prevalence of congenital abnormalities (hazard ratio = 1.01, 0.93-1.08) compared with nonexposed children (n = 61,718). No association was found between congenital abnormalities and duration of use during the first trimester. Increased prevalence was not observed for specific abnormalities, except for “medial cysts, fistula, sinus” (congenital abnormalities of the ear, face, and neck, ICD-10 code Q18.8, n = 43) with an adjusted hazard ratio of 2.15 (1.17-3.95).

Conclusion

Acetaminophen is not associated with an increased prevalence of congenital abnormalities overall or with any specific group of major abnormalities.

Section snippets

Materials and Methods

Data were obtained from the Danish National Birth Cohort (DNBC), a nation-wide study of 100,000 pregnant women and their offspring recruited between 1996 and 2003 (www.ssi.dk/sw9653.asp). Pregnant women were approached at the first prenatal care visit to a general practitioner, which usually took place after 6-10 weeks of gestation. Approximately 50% of all general practitioners in Denmark participated in the recruitment and approximately 60% of eligible women accepted the invitation and signed

Results

We identified 3784 liveborn singletons (4.3%) who had 5847 congenital abnormalities included in our study. The majority of children with an abnormality had an isolated congenital abnormality (n = 2460, 65%) and 1324 (35%) had 2 or more. Pregnant women who had a child with a congenital abnormality were similar to women in the cohort as a whole, in terms of demographic and lifestyle factors such as age, socioeconomic status, presence of a partner, and exposure to alcohol, tobacco, or drugs of

Comment

We believe this large prospective cohort study provides the most accurate evaluation of a potential teratogenic effect of acetaminophen to date. Our results are reassuring and rule out with some certainty a significant increase in the prevalence of frequent congenital abnormalities associated with use of this drug. We cannot rule out that the use of acetaminophen during pregnancy increases the prevalence of specific but infrequent congenital abnormalities, ie, congenital abnormalities of the

Acknowledgments

We thank Inge Eisensee (Danish Epidemiology Science Centre, University of Aarhus) for dataset preparation and Paco Fernández and Estel Plana (Centre for Research in Environmental Epidemiology) for their support in data management and analysis. We are especially grateful to the physicians, nurses, interviewers, and mothers without whose participation the study would not have been possible.

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    This study was supported by a major grant from the Danish National Research Foundation, with additional support from the Pharmacy Foundation, the Egmont Foundation, the March of Dimes Birth Defects Foundation, the Augustinus Foundation, and the Health Foundation.

    Cite this article as: Rebordosa C, Kogevinas M, Horváth-Puhó E, et al. Acetaminophen use during pregnancy: effects on risk for congenital abnormalities. Am J Obstet Gynecol 2008;198:178.e1-178.e7.

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