Fetal and neonatal outcomes in women taking domperidone during pregnancy

Abstract

The safety of domperidone in pregnancy remains unknown. Therefore, the study aimed to prospectively evaluate the fetal outcomes of women who were taking domperidone during pregnancy. In a prospective cohort study design, 120 1st- trimester pregnant women who were taking domperidone for controlling gastrointestinal tract symptoms and 212 age-matched pregnant women not exposed to any potential teratogenic agent, were followed-up until delivery. In the case group, domperidone was indicated for control of functional gastrointestinal disorders in 59.2%, the maximum dose was 30 mg/day and exposure occurred between 2(+4) and 20 weeks' gestation. Fetal outcomes including gestational age at birth, birth weight and length, head circumference at birth, and 1- and 5-min Apgar score were similar in the two study groups. There were three babies born with malformations in each group (OR = 0.6; 95% CI 0.1, 2.8). In conclusion, domperidone does not appear to be a major human teratogen. However, our findings require further confirmation in larger studies.

EUROmediCAT signal detection: an evaluation of selected congenital anomaly‐medication associations

“…While there are concerns about assisted reproduction in general in relation to CA risk , and two of our other signals discussed above are medications used in assisted reproduction, there is only minimal case report evidence relating to gonadotropin releasing hormone analogues, and none of these case reports relate to laterality anomalies. Previous studies of the propulsives have been negative regarding teratogenicity and there is no evidence to support our finding. The ordinary salts and bulk‐forming laxatives are generally assumed to be safe, have low bioavailablity, do not interfere with normal physiologic salt balance and therefore were not specifically studied.…”

“…Other types of antihypertensives, such as ace inhibitors, have been associated with an increased risk of CA [83] but the underlying maternal hypertension also appears to play a role in the development of CA [84]. [90][91][92][93][94], hypospadias or orofacial clefts [95] following exposure to the propulsives. There was no evidence of an association between transposition of the great vessels, ventricular septal defect (VSD), atrial septal defect (ASD), Tetralogy of Fallot, pulmonary valve stenosis or coarctation of the aorta [96] and first trimester exposure to metoclopramide (A03FA01).…”

Review article: the management of heartburn during pregnancy and lactation

“…Both groups were followed to delivery. In the domperidone group, 59.2% were using domperidone for functional GI disorders, at a maximum dose of 30 mg/d . In both groups, foetal outcomes were similar.…”

Migraine: navigating the hormonal minefield

“…Metoclopramide is often used in pregnancy for hyperemesis and is generally considered to be safe45 although there is a risk of dyskinesia. Domperidone is less likely to cause central effects such as dystonic reactions or sedation as it does not readily cross the blood–brain barrier but it has rarely been linked to a prolonged QT interval on ECG and there are few safety data in pregnancy 46. Prochlorperazine is commonly used in clinical practice although there is a risk of neonatal withdrawal during third trimester use 47…”