PMID-40329607 — Parker: GLP-1 RA Use in Pregnancy — Regulatory Safety Data (DOM 2025)

[DRAFT — authored 2026-04-20. Citation verified against PubMed and Diabetes Obes Metab 2026-04-20.]

Citation

Parker CH, Slattery C, Brennan DJ, le Roux CW. Glucagon-like peptide 1 (GLP-1) receptor agonists' use during pregnancy: Safety data from regulatory clinical trials. Diabetes Obes Metab. 2025;27(8):4102-4108. doi: 10.1111/dom.16437. PMID: 40329607.

External URL: PubMed

Study Design

Design: Review of pregnancy safety data from regulatory clinical trials
Data source: Unplanned pregnancies occurring during regulatory clinical trials submitted to the FDA and EMA
Scope: GLP-1 receptor agonists broadly — semaglutide, liraglutide, dulaglutide, exenatide, and other GLP-1 RAs
Intent: Characterize the available human pregnancy-exposure dataset (pooled regulatory submissions)

Key Findings

Pregnancy exposure dataset

Incidence of congenital abnormalities in humans following GLP-1 RA use during pregnancy appears relatively low based on pooled regulatory trial data
Limited sample size — most data comes from unplanned pregnancy exposures during trials (not planned-pregnancy studies)

Current recommendation

"GLP-1 receptor agonists should be stopped as soon as the patient becomes aware of a pregnancy."
Pre-pregnancy counseling: Discontinue ≥2 months before planned conception (per semaglutide half-life considerations)

Evidence gap

Authors emphasize: "Evidence in women having planned pregnancies is lacking." They call for establishing patient registries to capture exposure data during pregnancy prospectively.

Clinical Relevance

Parker 2025 is the most current pooled pregnancy-safety analysis for GLP-1 RAs as a class, drawing on the regulatory trial dataset across multiple agents and sponsors. Core teaching points:

Available human data is reassuring but limited — rates of congenital abnormalities appear low in pooled data, but absolute numbers are small and the population is selected (unplanned pregnancies during trials where most participants used contraception).
No GLP-1 RA is currently FDA-approved for use during pregnancy — all semaglutide products, tirzepatide, liraglutide, and other GLP-1 RAs are labeled not-recommended during pregnancy.
Standard clinical guidance remains unchanged: Discontinue upon pregnancy awareness. Counsel reproductive-age patients on contraception. Plan ≥2-month washout before planned conception (semaglutide); shorter washouts may be acceptable for shorter-half-life agents (liraglutide).
Registry call: Authors' recommendation for prospective pregnancy registries is notable — clinicians should consider participating in or referring patients to existing pregnancy registries (e.g., MotherToBaby) to build the evidence base.

Linked Peptides

Related Lessons

Lesson 5.2 — Semaglutide Deep Dive (Pregnancy/Nursing section)
Lesson 5.8 — Side Effect Management (special populations)

Related Studies

Existing pregnancy-specific language in Semaglutide label (REG-FDA-Wegovy-Label-2025-2026 – Current FDA Prescribing Information) — "not recommended" during pregnancy

PMID-40329607 – Parker GLP-1 Pregnancy Regulatory Safety Data