Senna treatment in pregnant women and congenital abnormalities in their offspring--a population-based case-control study.
Previously, the possible teratogenic effect of frequently used laxative drug, senna has not been checked in case-control epidemiological study. Objective of the study was the comparison of cases with congenital abnormalities (CAs) and their matched controls without CAs in the population-based large data set of the Hungarian Case-Control Surveillance System of Congenital Abnormalities. Of 22,843 cases with CA, 506 (2.2%) had mothers with senna treatment, while of 38,151 control newborn infants without CA, 937 (2.5%) were born to mothers with senna treatment (adjusted OR with 95% CI: 1.0, 0.9-1.1), and of 834 malformed controls with Down syndrome, 26 (3.1%) had mothers with the use of senna (OR with 95% CI: 0.7, 0.5-1.1). The range of senna doses was between 10mg and 30 mg, but most pregnant women used 20mg daily. The mothers with senna treatment showed the characteristics of pregnant women with constipation (elder with larger proportion of primiparae). There was no higher risk for 23 different CA groups after the senna treatment during the second and/or third gestational month of 260 mothers, i.e. in the critical period of most major CAs, compared with their 500 matched controls. Gestational age at delivery was somewhat longer (0.2 week) and the rate of preterm birth was lower (6.6% vs. 9.2%) in newborn infants without CA born to mothers with senna treatment compared with babies born to mothers without senna treatment. In conclusion, senna treatment did not associate with a higher risk of CAs in the offspring of pregnant women with constipation.
Acs
Nándor
N
Second Department of Obstetrics and Gynecology, Semmelweis University, School of Medicine, Budapest, Hungary.
Bánhidy
Ferenc
F
Puhó
Erzsébet H
EH
Czeizel
Andrew E
AE
D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000328:Adult; D016022:Case-Control Studies; D003248:Constipation / Q000188:drug therapy*; D003257:Consumer Product Safety; D005260:Female; D005865:Gestational Age; D006801:Humans; D006814:Hungary; D007231:Infant, Newborn; D054368:Laxatives / Q000008:administration & dosage / Q000009:adverse effects*; D050498:Live Birth; D011159:Population Surveillance; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D047928:Premature Birth / Q000139:chemically induced; D012042:Registries; D018570:Risk Assessment; D012676:Senna Extract / Q000008:administration & dosage / Q000009:adverse effects*; D055815:Young Adult
D054368:Laxatives; D012676:Senna Extract