Perinatal EvidenceCompass
Prepopulated workbenchMED-239

Substance-use disorder — nicotine

Cytisine

Nicotinic partial agonist smoking-cessation treatment

Brand / product examples: Cytisinicline · Tabex (jurisdiction-specific)

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
Cytisine
Entity type
single-ingredient drug
Active component(s)
Cytisine
Formulation / route / interval
Oral tablet regimen
Attachment entry
Cytisine/cytisinicline
Separate monograph status
Yes — investigational US/non-US marketed agent
Identity and cross-reference
Cytisine and cytisinicline refer to the same active molecule; one canonical row
Inventory verification confidence
High — direct status-changing or product-specific primary source

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

1 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.

C-023Provisional public source

Cytisinicline/cytisine lacks adequate pregnancy and lactation evidence and was not FDA-approved at the cutoff; the 2026 complete-response action does not provide reproductive reassurance.

Public-source certainty descriptor
Very low direct evidence; regulatory status checked to cutoff
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
Pregnancy and lactation
Comparator
Cytisine versus established cessation approaches
Effect or numbers carried forward

Pregnant/lactating participants excluded from development trials

Limitations

Complete-response details are sponsor-reported; international products/regimens vary

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