TOPLINE:

A large-scale study of postpartum domperidone use finds no association with an increased risk for psychosis (6.4 per 1000 person-years in both exposed and unexposed groups) or mental health-related emergency department visits and hospitalizations.

METHODOLOGY:

• Researchers conducted a retrospective cohort study of individuals who filled a domperidone prescription within 56 days of delivery between March 1, 2006, and March 1, 2022, in Ontario, Canada.
• Analysis included 4585 domperidone-exposed individuals matched 1:1 based on propensity score to an equal number of unexposed individuals.
• Primary outcome measures encompassed any healthcare contact for incident psychosis in the subsequent 365 days, with secondary outcomes including psychiatric emergency department visits or hospitalizations.
• Cox proportional hazards regression was utilized to compare outcome risk between individuals who initiated domperidone and those who did not.

TAKEAWAY:

• Compared with matched postpartum individuals who did not initiate domperidone, its use showed no association with psychosis (6.4 per 1000 person-years vs 6.4 per 1000 person-years; hazard ratio [HR], 1.00; 95% CI, 0.60-1.67).
• No association was found between domperidone use and emergency department visits or hospital admissions with mental health diagnoses (38.0 per 1000 person-years vs 43.4 per 1000 person-years; HR, 0.88; 95% CI, 0.71-1.08).
• The findings contrast with reports by Health Canada and the FDA warning about potential risks for psychiatric symptoms.
• According to the authors, clinical decisions regarding domperidone use after delivery should balance its modest effects on lactation with potential adverse effects.

IN PRACTICE:

“Although we found an association between domperidone exposure postpartum and initiation of psychoactive medications (particularly antidepressants) in the year after the index date, this finding was also observed in our tracer analysis of topical corticosteroids. Therefore, higher rates of psychoactive medication dispensing among domperidone-exposed individuals may in part reflect increased health care utilization among people using domperidone postpartum. In addition, filling a prescription for domperidone may signal breastfeeding difficulties, which have themselves been independently associated with postpartum depression,” wrote the authors of the study.

SOURCE:

The study was led by Jonathan Zipursky, MD, PhD, Department of Medicine, University of Toronto, and Division of Clinical Pharmacology and Toxicology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. It was published online in Obstetrics & Gynecology.

LIMITATIONS:

According to the authors, despite using propensity score methods to balance measured confounders, the findings may be influenced by unmeasured confounding factors such as patient race, tobacco use, illicit drug use, and other social factors. The analysis was limited to Ontarians eligible for public drug benefits, potentially affecting generalizability. The researchers lacked reliable data on breastfeeding status, with more than 35% missing data for intention to breastfeed at delivery in the Better Outcomes Registry and Network database. Additionally, the study could only track prescriptions dispensed from pharmacies, without confirming actual medication adherence.

DISCLOSURES:

Zipursky disclosed receiving payments for medicolegal opinions related to drug safety and effectiveness and serving as a medical advisor for First Exposure. Tara Gomes reported receiving funding from the Ontario Ministry of Health, Ontario College of Pharmacists, Canadian Institutes of Health Research (CIHR), and Canadian Drug Association (CDA), and stipends from Indigenous Services Canada. Mina Tadrous reported receiving funding from the Ontario Ministry of Health, Ontario College of Pharmacists, CIHR, CDA, and Health Canada unrelated to this work. Simone N. Vigod reported receiving royalties from UpToDate, Inc., for authorship of materials related to depression and pregnancy. The other authors reported having no potential conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.