Aim

Hemorrhoids are common during pregnancy. In spite of this, safety of their pharmacological treatment has not been assessed. The aim of this study is to determine the association between exposure to antihemorrhoidal agents during the first trimester and congenital malformations.

Methods

We identified all pregnancies resulting in a live birth between 1997 and 2009 through the Danish Medical Birth Registry. Redeemed prescriptions were identified through the Danish Register of Medicinal Product Statistics, and diagnoses of major congenital malformations through the Danish National Hospital Register. The risk of congenital malformations was calculated using multivariable logistic regression models adjusted for potential confounding variables.

Results

We identified 844 194 pregnancies; of which 7210 (0.85%) redeemed a prescription for an antihemorrhoidal agent during the first trimester. All redeemed drugs contained corticosteroids; either hydrocortisone (n=4553) or fluocortolone (n=2433). The risk of major congenital malformations for any antihemorrhoidal agent was; adjusted OR 1.03 (95% CI 0.91-1.17). Stratifying analyses for different corticosteroids gave no elevated risk of major congenital malformations.

Conclusion

We found no association between redeeming a prescription for an antihemorrhoidal agent during the first trimester and congenital malformations. To our knowledge, this is the first study to analyze this relation.