Perinatal EvidenceCompass
Prepopulated workbenchMED-066

Mood stabilizers/antiseizure — other

Pregabalin

Antiseizure medication with off-label psychiatric use; established bipolar efficacy must not be assumed

Not a categorical safety rating

This record organizes questions; it does not close them.

The clinical fields and position statements are prepopulated from the public-source corpus. They have not completed individual dual extraction, formal appraisal, exact-label reconciliation, or multidisciplinary sign-off. Do not use this page to justify abrupt discontinuation or reflexive switching.

Inventory identity

What this record represents

Canonical generic name
Pregabalin
Entity type
single-ingredient drug
Active component(s)
Pregabalin
Formulation / route / interval
Oral; formulation varies
Attachment entry
Pregabalin
Separate monograph status
No — cross-reference shared molecule monograph
Identity and cross-reference
Also: anxiety and insomnia
Inventory verification confidence
Moderate — molecule-level source; exact product/jurisdiction pending

Decision taxonomy

Five positions kept separate

These are workbench statements for reviewer execution. They are not independently commissioned, patient-specific recommendations.

  1. 01

    Stable continuation

    Workbench statement

    Do not withhold or discontinue solely because of pregnancy or lactation. For this record, assess indication, prior response, relapse severity, dose/formulation, alternatives, exposure timing, and mapped evidence; individual commissioned adjudication remains pending.

  2. 02

    New initiation in pregnancy

    Workbench statement

    For a new start, prefer an effective option with the strongest diagnosis-specific efficacy and reproductive evidence when clinically suitable. This record has not received an individual, independently verified initiation ranking.

  3. 03

    Switch before conception

    Workbench statement

    Before conception, consider a switch only when expected benefit exceeds relapse, withdrawal, failed-switch, and dual-exposure risks. Build and monitor the plan before pregnancy when feasible; no universal switch direction is assigned here.

  4. 04

    Unplanned exposure

    Workbench statement

    After unplanned exposure, confirm product, route, dose, timing, indication, co-exposures, and symptoms; do not advise abrupt cessation. Use the mapped evidence and current label to decide whether any targeted fetal assessment is indicated.

  5. 05

    Delivery, postpartum & lactation

    Workbench statement

    Create separate delivery, postpartum-dose, neonatal-observation, and lactation plans. Do not infer breastfeeding suitability from pregnancy evidence or routinely taper before delivery without drug-specific support.

Linked evidence

2 mapped claim summaries

Mapping can include class-wide, framework, formulation, regulatory, or evidence-gap claims. A linked claim is not necessarily a drug-specific causal estimate.

B-022Provisional public source

Pregabalin data are compatible with no increase and with a small MCM increase; a large Nordic estimate was not statistically significant.

Public-source certainty descriptor
low-to-moderate—observational cohort
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
first trimester
Comparator
unexposed pregnancies
Effect or numbers carried forward

MCM 5.9% versus 4.1%; adjusted prevalence ratio 1.14 (95% CI 0.96–1.35)

Limitations

Confidence interval includes no association; confounding by pain, anxiety, epilepsy, and co-medications.

Sources, citation controls, and verification state

Linked sources

PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending
B-031Provisional public source

Once pregnancy is established, replacing an effective antiseizure medicine requires caution because seizure recurrence can harm the pregnant patient and fetus.

Public-source certainty descriptor
guideline recommendation
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
after conception
Comparator
continuing effective therapy
Effect or numbers carried forward

No single effect estimate; AAN/AES/SMFM caution

Limitations

Decision varies by seizure syndrome, prior control, dose, and drug-specific fetal risk.

Sources, citation controls, and verification state
PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending