Documentation
Help Guide
Pregnancy & lactation safety screening
Understanding safety categories and risk assessments
Pregnancy & Lactation Safety Screening
Use MedSafe's safety screening tools to assess drug safety during pregnancy and breastfeeding.
Pregnancy Safety Categories
FDA Categories
- Category A: Adequate, well-controlled studies in pregnant women have not shown increased risk
- Category B: Animal studies show no risk, but no adequate human studies
- Category C: Animal studies show adverse effects, but potential benefits may warrant use
- Category D: Evidence of human fetal risk, but benefits may warrant use in life-threatening situations
- Category X: Studies show fetal abnormalities; risks clearly outweigh benefits
Australian Categories (TGA)
- A: Taken by many pregnant women without harmful effects
- B1-B3: Limited human data, varying levels of animal study results
- C: May cause harmful effects but benefits may outweigh risks
- D: Known to cause harmful effects
- X: High risk of permanent damage; should not be used
Using the Pregnancy Checker
- Navigate to Tools → Safety Screening
- Select "Pregnancy Safety Checker"
- Add drugs by searching and selecting
- Review safety categories and recommendations
- Export results for patient counseling
Lactation Safety Assessment
Evaluate drug safety during breastfeeding:
- Compatible: Safe for use during breastfeeding
- Probably Compatible: Limited data suggests safety
- Use with Caution: Monitor infant for effects
- Contraindicated: Avoid during breastfeeding
Clinical Considerations
Pregnancy Screening
- Consider gestational age (first trimester most critical)
- Evaluate maternal condition severity
- Assess availability of safer alternatives
- Document counseling and decision rationale
Lactation Screening
- Consider infant age and health status
- Evaluate drug concentration in breast milk
- Monitor infant for adverse effects
- Consider timing of doses relative to feeding
Safety screening tools are available for Professional tier users. Always consult current clinical guidelines and consider individual patient factors.
Documentation and Counseling
Professional users can:
- Export safety assessment reports
- Generate patient counseling materials
- Save assessments to patient records
- Share recommendations with healthcare team