Is Bentyl (dicyclomine) safe to use during pregnancy?

Safety of Bentyl (Dicyclomine) During Pregnancy

Bentyl (dicyclomine) is classified as FDA Pregnancy Category B and can be used during pregnancy if clearly needed, as epidemiologic studies have not shown increased risk of structural malformations at recommended doses. 1

Evidence on Safety

Dicyclomine hydrochloride has been studied extensively regarding pregnancy safety:

• According to the FDA drug label, epidemiologic studies showed no increased risk of structural malformations among babies born to women who took products containing dicyclomine at doses up to 40 mg/day during the first trimester 1
• Animal reproduction studies performed in rats and rabbits at doses up to 33 times the maximum recommended human dose revealed no evidence of fetal harm 1
• Dicyclomine was previously a component of "Bendectin" (with doxylamine and pyridoxine), which was extensively studied and found not to increase the risk of birth defects 2

Considerations for Use During Pregnancy

When considering dicyclomine during pregnancy:

1. Risk-Benefit Assessment:

   • Use only if clearly needed and benefits outweigh potential risks 1
   • Consider the severity of maternal symptoms requiring treatment
   • Start at the lowest effective dose

2. Timing of Use:

   • While the FDA label doesn't specify trimester-specific restrictions, general medication principles suggest minimizing medication exposure during the first trimester when possible

3. Monitoring:

   • Regular follow-up to assess continued need for medication
   • Adjust dosing as needed based on symptom control

Breastfeeding Considerations

• Dicyclomine is contraindicated during breastfeeding 1
• The drug is excreted in human milk and may cause serious adverse reactions in breastfed infants
• If treatment is necessary during the postpartum period, a decision should be made to either discontinue breastfeeding or discontinue the medication 1

Alternative Approaches

If treatment is needed but concerns exist about using dicyclomine:

• Consider non-pharmacological approaches first
• Discuss with a healthcare provider about alternative medications with established safety profiles during pregnancy

Key Points to Remember

• Pregnancy Category B indicates animal studies have not demonstrated risk, but adequate controlled studies in pregnant women are lacking
• Use only when clearly needed and benefits outweigh potential risks
• Contraindicated during breastfeeding
• Regular monitoring is essential if used during pregnancy

While the FDA classification suggests relative safety during pregnancy, each clinical situation requires individual assessment of the maternal condition requiring treatment and potential fetal risks.