Is domperidone safe to use during pregnancy?

Domperidone Safety During Pregnancy

Domperidone should be avoided during pregnancy due to limited safety data and potential risks, with the FDA not approving it for any human use in the United States. 1

Safety Profile

• Domperidone is not approved for any indication in humans in the United States, and the FDA has explicitly warned against its use, including an import alert stating that importation of domperidone is illegal with limited exceptions 2
• The FDA label specifically cautions that pregnant women should use caution when handling domperidone (even in veterinary formulations), as systemic exposure may affect reproductive hormones 1
• Limited studies have investigated domperidone use in pregnancy, with one prospective cohort study of 120 first-trimester exposures suggesting no major teratogenic effects, though the authors emphasized the need for larger confirmatory studies 3
• A more recent study using the EFEMERIS database found comparable malformation rates between exposed and unexposed pregnancies, though this requires further validation 4

Risk-Benefit Assessment

• When considering medications during pregnancy, the American Heart Association recommends avoiding drugs in the first trimester when the risk of congenital malformations is greatest 5
• For medications with limited safety data like domperidone, use during pregnancy may only be justified if benefits clearly outweigh risks, with the lowest recommended dose used initially 5
• A common pitfall is failing to discuss alternative treatment options with better established safety profiles during pregnancy 5

Clinical Recommendations

• For gastrointestinal disorders during pregnancy (a common indication for domperidone):
  • Consider safer alternatives with established safety profiles during pregnancy 5
  • For severe nausea and vomiting in pregnancy, medications like metoclopramide have more established safety data 6
• For lactation enhancement (an off-label use of domperidone):
  • Domperidone is sometimes illegally obtained and used to increase milk production, despite FDA warnings 2
  • There is limited quality evidence for effectiveness in lactation enhancement, which does not offset the safety concerns from a public health perspective 2
  • Non-pharmacological interventions for lactation support should be exhausted first 7

Special Considerations

• Cardiac risks associated with domperidone include QT prolongation, torsades de pointes, and sudden cardiac death, which have been reported even among lactating women 2
• The safety of domperidone in lactating women and their nursing children has not been adequately evaluated 1
• If a medication is absolutely necessary during pregnancy for severe gastrointestinal symptoms, consult with maternal-fetal medicine specialists to select agents with better established safety profiles 6

Alternative Approaches

• For gastrointestinal motility disorders, consider medications with better established safety profiles during pregnancy, such as metoclopramide (when benefits outweigh risks) 6
• For lactation support, focus on non-pharmacological interventions including lactation consultation, optimizing breastfeeding technique, and increased frequency of breastfeeding or pumping 7