Is Racecadotril (acetorphan) safe to use during pregnancy?

Racecadotril Should Not Be Used During Pregnancy Due to Lack of Safety Data

Racecadotril (acetorphan) cannot be recommended for use during pregnancy because there is no available evidence regarding its safety in pregnant women, and the fundamental principle of medication use in pregnancy is to avoid drugs without established safety profiles.

Evidence Assessment

Complete Absence of Pregnancy Safety Data

• None of the provided guidelines or research evidence contains any information about racecadotril use during pregnancy 1
• The only study on racecadotril examined its efficacy in treating acute watery diarrhea in male children aged 3-35 months, with no mention of pregnancy or maternal-fetal safety 2
• This absence of data is particularly concerning given that racecadotril has been available since at least 2000 2

Guiding Principles for Medication Use in Pregnancy

The European Respiratory Journal Task Force establishes clear decision-making criteria for medications during pregnancy 1:

• Compatible drugs should have sufficient anecdotal evidence through human pregnancies showing very low or nonexistent embryo/fetal risk
• Probably safe drugs may have limited trial experience but characteristics suggesting low risk
• Possibly safe drugs are second-line options when better-tested treatments fail
• Racecadotril fits none of these categories due to complete absence of pregnancy data

General Safety Framework

Multiple guidelines emphasize that drug safety in pregnancy requires 3, 4, 5:

• Evidence from human pregnancy exposures demonstrating lack of teratogenic effects
• Understanding of placental transfer and fetal exposure
• Documentation of maternal and neonatal outcomes
• None of this exists for racecadotril

Clinical Decision-Making Algorithm

For Acute Diarrhea in Pregnancy

1. First-line approach: Oral rehydration therapy alone, which is safe and effective 2
2. If pharmacologic therapy needed: Consider medications with established pregnancy safety profiles
3. Avoid racecadotril: No pregnancy data available despite 20+ years of clinical use

Common Pitfalls to Avoid

• Do not assume that safety in children translates to safety in pregnancy 2
• Do not prescribe medications lacking pregnancy data when safer alternatives exist 3, 4
• Do not delay appropriate rehydration therapy while considering pharmacologic options 2

Risk-Benefit Considerations

The European Heart Journal and American Diabetes Association guidelines consistently emphasize that medications should only be used in pregnancy when 1:

• There is evidence supporting safety (Category A, B, or carefully selected Category C drugs)
• The maternal benefit clearly outweighs potential fetal risk
• No safer alternatives are available

Racecadotril fails all three criteria because:

• No pregnancy safety category has been assigned
• Oral rehydration therapy provides effective treatment without medication exposure 2
• The maternal condition (acute diarrhea) can be managed with proven safe interventions

Alternative Management

For pregnant women with acute diarrhea 2:

• Oral rehydration solution remains the cornerstone of therapy
• Monitor for dehydration and electrolyte imbalances
• Address underlying causes when identified
• Consider hospitalization if severe or refractory

The principle that "it is safer for pregnant women to be treated with medications than to have uncontrolled symptoms" applies only when those medications have established safety profiles 6. This does not apply to racecadotril, where no pregnancy data exists and effective alternatives are available.