Is Stemetil (prochlorperazine) contraindicated during pregnancy and while breastfeeding?

Stemetil (Prochlorperazine) in Pregnancy and Lactation

Prochlorperazine is NOT contraindicated in pregnancy or breastfeeding; it is explicitly recommended as a safe first-line antiemetic option in both situations according to current high-quality guidelines. 1

Use During Pregnancy

Prochlorperazine is compatible with use throughout all trimesters of pregnancy, including peri-conception, first trimester, and second/third trimesters. 1

Evidence Supporting Safety:

• The 2023 European Association for the Study of the Liver (EASL) guidelines explicitly list prochlorperazine as compatible with pregnancy across all trimesters when used for management of hyperemesis gravidarum and nausea/vomiting. 1
• The American College of Obstetricians and Gynecologists (ACOG) considers promethazine (a similar phenothiazine antiemetic) as safe first-line pharmacologic therapy during pregnancy, and prochlorperazine shares this safety profile. 2

Important FDA Labeling Caveat:

• The FDA label states that "safety for the use of prochlorperazine during pregnancy has not been established" and recommends use only for "severe nausea and vomiting that are so serious and intractable" where benefits outweigh risks. 3
• However, this conservative FDA labeling is superseded by extensive clinical guideline evidence demonstrating safety. 1
• The FDA label notes potential neonatal effects (prolonged jaundice, extrapyramidal signs, hyperreflexia/hyporeflexia) when phenothiazines are used near delivery, though these are typically self-limited. 3

Clinical Algorithm for Pregnancy Use:

• First-line pharmacologic option when non-pharmacologic approaches (dietary modifications, ginger, vitamin B6) fail for nausea and vomiting in pregnancy. 1, 2
• Can be used throughout pregnancy without requiring discontinuation or switching. 1
• Monitor neonates for extrapyramidal symptoms if used near delivery, though serious complications are rare. 3

Use During Breastfeeding

Prochlorperazine is compatible with breastfeeding. 1

Evidence Supporting Safety:

• The 2023 EASL guidelines explicitly state prochlorperazine is compatible with breastfeeding. 1
• The 2020 Association of Anaesthetists guideline confirms that prochlorperazine has low oral bioavailability due to high first-pass metabolism, making it compatible with breastfeeding. 1
• Phenothiazines are excreted in breast milk, but the amount transferred is minimal due to poor oral absorption by the infant. 1, 3

Practical Considerations:

• No need to interrupt breastfeeding when using prochlorperazine. 1
• The drug's high first-pass metabolism limits infant exposure even when present in milk. 1
• Breastfeeding should be encouraged as benefits outweigh theoretical minimal risks. 4, 5

Common Pitfall to Avoid

Do not discontinue prochlorperazine or advise against breastfeeding based solely on conservative FDA labeling. The clinical guideline evidence from EASL (2023) and the Association of Anaesthetists (2020) provides robust support for safety in both pregnancy and lactation. 1 The FDA's cautious language reflects regulatory conservatism rather than evidence of harm. 3