ArticlePharmaceuticals (Basel, Switzerland)2024
Drug Safety During Breastfeeding: A Comparative Analysis of FDA Adverse Event Reports and LactMed
Article in Pharmaceuticals (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Assessing the Safety of Medications During Lactation: Lactation safety.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- SafeRx: A Canonical Pharmaceutical Knowledge Integration Framework for Multimodal Medication Safety.Bioengineering (Basel, Switzerland) · 2026Article
- Safe use of human milk for preterms in the context of maternal polypharmacy: a framework to improve practices.Pediatric research · 2026Review
- A Noisy Signal? Geographic Bias in FAERS Reports Linking Paracetamol to Autism Spectrum Disorder.Journal of clinical medicine · 2026Article
- Lorazepam during breastfeeding: a pharmacokinetic case report and exploratory pharmacovigilance assessment - a contribution from the ConcePTION project.Frontiers in pharmacology · 2026Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
objectivesWhile breastfeeding is highly recommended, breastfed infants may be exposed to drugs by milk due to maternal pharmacotherapy, resulting in a risk of adverse drug events (ADE) or reactions (ADRs). The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is an online pharmacovigilance database, while the Drugs and Lactation Database (LactMed
methodsThe FAERS database was explored (29 July 2024) for ADEs related to drug exposure during lactation to determine annual trends, infant outcomes, and regions of reporting. The active pharmaceutical ingredients (APIs) associated with these ADEs were categorized based on the Anatomical Therapeutic Chemical (ATC, first level) classification. The top five APIs in each ATC group were explored in terms of the type of ADEs reported and compared to information in LactMed
resultsIn total, 2628 ADEs were obtained from the FAERS database, with increased reporting over time. In the FAERS database, 68.4% of the patients were under 2 months old, 5.5% had life threatening ADEs, and 3.6% died, while 84.70% of the cases were categorized as serious. Most ADEs were from North America (44.9%). Most drugs (50.9%) were nervous system drugs. The most frequent reported outcome was "other outcomes (without additional subdivision or information)" (58.2%), reflecting the diversity in outcomes reported. When related to the same drug, the FAERS database and LactMed
conclusionsThe FAERS database is a useful tool to detect potential ADEs (rather sensitive), without ADR assessment, while LactMed
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