Is Dicycloamine (anticholinergic medication) safe to use during lactation, especially in newborns or premature infants?

Dicyclomine During Lactation

Direct Recommendation

Dicyclomine should not be used during breastfeeding and is contraindicated in lactating women. 1

FDA Labeling and Safety Warnings

The FDA explicitly advises that dicyclomine hydrochloride should not be used while breastfeeding infants and specifically warns parents and caregivers not to administer dicyclomine in infants less than 6 months of age. 1 This represents the highest level of regulatory guidance available and takes precedence over general principles of medication use during lactation.

Key Safety Concerns

Anticholinergic Effects in Infants

• Dicyclomine poses particular risks to young infants due to its anticholinergic properties, which can cause serious adverse effects including respiratory depression, apnea, seizures, and cardiovascular instability when transferred through breast milk. 1

• Infants under 6 months are especially vulnerable due to immature hepatic and renal function, making them unable to adequately metabolize and eliminate anticholinergic medications. 1

Additional Anticholinergic Risks

• Dicyclomine can cause decreased sweating and heat prostration (fever and heat stroke) in high environmental temperatures, and may produce drowsiness or blurred vision—effects that could theoretically impact both mother and infant. 1

Clinical Algorithm for Management

When a breastfeeding mother requires treatment for conditions typically managed with dicyclomine (such as irritable bowel syndrome or intestinal cramping):

1. Discontinue breastfeeding if dicyclomine is medically necessary for the mother, as the FDA explicitly contraindicates its use during lactation. 1

2. Consider alternative therapies first, including non-pharmacologic interventions or medications with established safety profiles during breastfeeding. 2, 3

3. If antispasmodic therapy is essential, consult specialized lactation pharmacology resources to identify safer alternatives, as most commonly used drugs are relatively safe for breastfed babies when appropriate alternatives exist. 2

Important Clinical Pitfall

Do not rely on general principles that "most drugs are safe during breastfeeding" when specific FDA contraindications exist. 1 While it is true that most medications transfer into breast milk in small amounts and are generally safe 2, 4, dicyclomine represents a specific exception due to documented risks in young infants and explicit regulatory warnings. 1