{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T19:51:00Z","timestamp":1791575460371,"version":"4.3.4"},"reference-count":37,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T00:00:00Z","timestamp":1733702400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Scientific and Technological Research Council of Turkey (TU\u0308BI\u0307TAK)","award":["no: 53325897-115.02-476393"],"award-info":[{"award-number":["no: 53325897-115.02-476393"]}]},{"name":"Scientific and Technological Research Council of Turkey (TU\u0308BI\u0307TAK)","award":["no: 7167784\/VKB-32"],"award-info":[{"award-number":["no: 7167784\/VKB-32"]}]},{"name":"Scientific and Technological Research Council of Turkey (TU\u0308BI\u0307TAK)","award":["FWO; 1246425N"],"award-info":[{"award-number":["FWO; 1246425N"]}]},{"name":"Hacettepe University European Union Office","award":["no: 53325897-115.02-476393"],"award-info":[{"award-number":["no: 53325897-115.02-476393"]}]},{"name":"Hacettepe University European Union Office","award":["no: 7167784\/VKB-32"],"award-info":[{"award-number":["no: 7167784\/VKB-32"]}]},{"name":"Hacettepe University European Union Office","award":["FWO; 1246425N"],"award-info":[{"award-number":["FWO; 1246425N"]}]},{"name":"Research Foundation Flanders","award":["no: 53325897-115.02-476393"],"award-info":[{"award-number":["no: 53325897-115.02-476393"]}]},{"name":"Research Foundation Flanders","award":["no: 7167784\/VKB-32"],"award-info":[{"award-number":["no: 7167784\/VKB-32"]}]},{"name":"Research Foundation Flanders","award":["FWO; 1246425N"],"award-info":[{"award-number":["FWO; 1246425N"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background\/Objectives: While 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\u00ae) includes accurate and evidence-based information on levels of substances in breast milk and infant blood, and possible ADRs in nursing infants. We aimed to explore the FAERS database and compare ADE\/ADR information patterns between both databases. Methods: The 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\u00ae. Results: In 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 \u201cother outcomes (without additional subdivision or information)\u201d (58.2%), reflecting the diversity in outcomes reported. When related to the same drug, the FAERS database and LactMed\u00ae resource exhibited both similarities and differences in the types of reported ADE\/ADR. Conclusions: The FAERS database is a useful tool to detect potential ADEs (rather sensitive), without ADR assessment, while LactMed\u00ae provides guidance driven by relevant ADRs (rather specific). The FAERS database is useful to obtain exploratory information about ADEs during lactation to increase the knowledge about drug safety during breastfeeding and the awareness of the possible risks in nursing infants, while LactMed\u00ae translates all available information into guidance.<\/jats:p>","DOI":"10.3390\/ph17121654","type":"journal-article","created":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T06:16:14Z","timestamp":1733724974000},"page":"1654","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Drug Safety During Breastfeeding: A Comparative Analysis of FDA Adverse Event Reports and LactMed\u00ae"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1843-3424","authenticated-orcid":false,"given":"H\u00fclya","family":"Tezel Yal\u00e7\u0131n","sequence":"first","affiliation":[{"name":"Department of Toxicology, Faculty of Pharmacy, Hacettepe University, 06100 Ankara, T\u00fcrkiye"},{"name":"Rega Institute for Medical Research, KU Leuven, 3000 Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadir","family":"Yal\u00e7\u0131n","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, Faculty of Pharmacy, Hacettepe University, 06100 Ankara, T\u00fcrkiye"},{"name":"Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4130-5869","authenticated-orcid":false,"given":"Michael","family":"Ceulemans","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium"},{"name":"Child and Youth Institute, KU Leuven, 3000 Leuven, Belgium"},{"name":"Research Foundation Flanders (FWO), 1000 Brussels, Belgium"},{"name":"IQ Health, Radboud University Medical Center, 6525 XZ Nijmegen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9921-5105","authenticated-orcid":false,"given":"Karel","family":"Allegaert","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium"},{"name":"Child and Youth Institute, KU Leuven, 3000 Leuven, Belgium"},{"name":"Department of Development and Regeneration, KU Leuven, 3000 Leuven, Belgium"},{"name":"Department of Hospital Pharmacy, Erasmus MC, 3015 GD Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,12,9]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1870","DOI":"10.1002\/psp4.13195","article-title":"A literature review of drug transport mechanisms during lactation","volume":"13","author":"Gong","year":"2024","journal-title":"CPT Pharmacomet. 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