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🤰 Medication Use in Pregnancy — Reference

UseUnderstand the labelling framework and where to find evidence-based per-drug guidance — not a per-drug rating…

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SourceFDA Pregnancy and Lactation Labeling Rule (PLLR), 2015; MotherToBaby

Runs locally in your browser (no PHI uploaded). For licensed clinicians — not a substitute for clinical judgement.
Stored on this device for revisit reminders

This-shift next steps

After scoring: open the scene pack, peer scores, and the matching pathway. Local reference — no HIS write.

Score + version; reference only — not a substitute for care · no HIS write

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Methodology · worked example, guidelines & full notes
Clinical takeaway

The old letter categories were misread as a risk ladder and are historical only.

When to use

Understand the labelling framework and where to find evidence-based per-drug guidance — not a per-drug rating itself.

How it works

PLLR (2015) replaced A/B/C/D/X letters with narrative sections: pregnancy, lactation, and females/males of reproductive potential.

Key points

  • The old letter categories were misread as a risk ladder and are historical only.
  • Weigh the risk of untreated maternal disease against the drug risk.
  • Prefer well-evidenced agents at the lowest effective dose; organogenesis (≈ 3–8 weeks) is most sensitive.
  • Consult MotherToBaby/LactMed and the latest label for specific drugs.

References

Worked calculation

The values below come from this tool's own example placeholders and are computed server-side with the formula shown on this page, so the arithmetic can be checked quickly. It demonstrates how to substitute values only — it is not clinical advice and not a real case.

ViewPLLR labelling rule

→ReferencePregnancy and Lactation Labeling Rule (PLLR, from June 2015)

  • Removed:Abolished A/B/C/D/X letter grades
  • Pregnancy:Narrative: risk summary, clinical considerations, data (incl. exposure registries)
  • Lactation:Drug in milk, effect on the breastfed infant, effect on milk production
ViewFormer FDA categories (withdrawn)

→ReferenceFormer FDA pregnancy categories A/B/C/D/X (withdrawn 2015)

  • A:Controlled studies show no fetal risk (e.g. appropriate folate, levothyroxine)
  • B:No risk in animals but no human controlled data, or animal risk not confirmed in humans
  • C:Adverse in animals / no human controlled data → weigh risk vs benefit (most drugs were here)
Verification & sources · governance
FAQ

Frequently asked questions

What are the limits and cautions when using Medication Use in Pregnancy — Reference?
For licensed clinicians and clinical researchers. Interpret results with history, investigations and local protocols; not a diagnosis or prescription, and not a substitute for multidisciplinary decision-making or local guidelines.
Does Medication Use in Pregnancy — Reference upload patient data? Where is it calculated?
Calculation runs locally in the browser; inputs and results are not uploaded. For licensed clinicians only; interpret with history, investigations and local protocols — not a diagnosis or prescription.
How is Medication Use in Pregnancy — Reference calculated in practice? Can you show a worked example?
Inputs: View PLLR labelling rule → Result: Reference Pregnancy and Lactation Labeling Rule (PLLR, from June 2015)(Removed: Abolished A/B/C/D/X letter grades, Pregnancy: Narrative: risk summary, clinical considerations, data (incl. exposure registries), Lactation: Drug in milk, effect on the breastfed infant, effect on milk production) Inputs: View Former FDA categories (withdrawn) → Result: Reference Former FDA pregnancy categories A/B/C/D/X (withdrawn 2015)(A: Controlled studies show no fetal risk (e.g. appropriate folate, levothyroxine), B: No risk in animals but no human controlled data, or animal risk not confirmed in humans, C: Adverse in animals / no human controlled data → weigh risk vs benefit (most drugs were here))
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