{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T08:55:23Z","timestamp":1791276923515,"version":"4.1.0"},"reference-count":21,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T00:00:00Z","timestamp":1791244800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T00:00:00Z","timestamp":1791244800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"abstract":"Medication use during breastfeeding is common, yet data on drug transfer into breast milk and infant exposure remain limited. This study describes real\u2010world requests concerning medication compatibility with breastfeeding managed by the Lyon pharmacovigilance center over five years. We conducted a descriptive observational study including all requests recorded between January 2019 and December 2023. Characteristics of infants, medications involved, and recommendations provided were analyzed. A total of 2,473 requests were included, corresponding to approximately 500 per year. Most requests originated from patients (44%), allied health professionals (29%), or specialists (25%), with two thirds occurring postpartum. Overall, our recommendations supported breastfeeding in 87% of cases, either unconditionally or under specific conditions, such as clinical monitoring, therapeutic adjustments, or timing strategies. Only 13% of cases resulted in an unfavorable recommendation, for either treatment or breastfeeding discontinuation, due to formal contraindications, insufficient therapeutic benefit, or limited safety data. Polytherapy was observed in 35% of cases and was associated with more restrictive recommendations. Medications used for chronic conditions accounted for 36% of cases such as antihypertensives, antiepileptics, or psychotropic agents. Treatments for acute conditions included anti\u2010infectives, analgesics, contrast agents, or anesthetics. Reported adverse effects in infants were rare and non\u2010serious. In most cases, a recommendation supporting breastfeeding during maternal treatment, with or without conditions, was provided. However, uncertainty persists, particularly in complex or poorly documented situations. This work highlights the need for reliable, accessible information, inclusion of breastfeeding women in clinical research, and strengthened regulatory and postmarketing evaluation strategies to ensure infant safety health.<\/jats:p>","DOI":"10.1002\/cpt.70518","type":"journal-article","created":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T08:42:28Z","timestamp":1791276148000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Medication Use During Breastfeeding\u2014An Understudied Population: A Five\u2010Year Experience in the Pharmacovigilance Center of Lyon"],"prefix":"10.1002","author":[{"given":"Blandine","family":"Bertin","sequence":"first","affiliation":[{"name":"Pharmacovigilance Center, Hospital University Pharmacotoxicology Department Hospices civils de Lyon Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aurore","family":"Gouraud","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Center, Hospital University Pharmacotoxicology Department Hospices civils de Lyon Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3677-4919","authenticated-orcid":false,"given":"Anthony","family":"Facile","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Center, Hospital University Pharmacotoxicology Department Hospices civils de Lyon Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fanny","family":"Ledys","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Center, Hospital University Pharmacotoxicology Department Hospices civils de Lyon Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabrina","family":"Pierre","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Center, Hospital University Pharmacotoxicology Department Hospices civils de Lyon Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V\u00e9ronique","family":"Pizzoglio","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Center, Hospital University Pharmacotoxicology Department Hospices civils de Lyon Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierry","family":"Vial","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Center, Hospital University Pharmacotoxicology Department Hospices civils de Lyon Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marine","family":"Auffret","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Center, Hospital University Pharmacotoxicology Department Hospices civils de Lyon Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5735-4905","authenticated-orcid":false,"given":"Marina","family":"Atzenhoffer","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Center, Hospital University Pharmacotoxicology Department Hospices civils de Lyon Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,6]]},"reference":[{"key":"e_1_2_10_1_1","first-page":"1","article-title":"Breastfeeding and maternal and infant health outcomes in developed countries","volume":"153","author":"Ip S.","year":"2007","journal-title":"Evid. Rep. Technol. Assess"},{"key":"e_1_2_10_2_1","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2022-057988","article-title":"Policy statement: breastfeeding and the use of human Milk","volume":"150","author":"Meek J.Y.","year":"2022","journal-title":"Pediatrics"},{"key":"e_1_2_10_3_1","doi-asserted-by":"crossref","first-page":"354","DOI":"10.1055\/s-0038-1657766","article-title":"Breastfeeding and the benefits of lactation for Women's health","volume":"40","author":"Del Ciampo L.A.","year":"2018","journal-title":"Rev. Bras. Ginecol. Obstet."},{"key":"e_1_2_10_4_1","unstructured":"Breastfeeding. Accessed June 9 2026."},{"key":"e_1_2_10_5_1","unstructured":"ICH E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials \u2013 Scientific guideline | European Medicines Agency (EMA) (2025). Accessed June 25 2026."},{"key":"e_1_2_10_6_1","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1186\/s13006-025-00797-3","article-title":"Drug exposure during breastfeeding: a descriptive population\u2010based cohort study with SIDIAP database","volume":"21","author":"Giner\u2010Soriano M.","year":"2025","journal-title":"Int. Breastfeed. J."},{"key":"e_1_2_10_7_1","doi-asserted-by":"crossref","first-page":"2979","DOI":"10.1002\/bcp.70139","article-title":"Prescription drug use in breastfeeding mothers and infant exposure: a register\u2010based cohort study","volume":"91","author":"Gotfredsen D.R.","year":"2025","journal-title":"Br. J. Clin. Pharmacol."},{"key":"e_1_2_10_8_1","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1186\/s13006-024-00628-x","article-title":"The use of prescription medications and non\u2010prescription medications during lactation in a prospective Canadian cohort study","volume":"19","author":"Soliman Y.","year":"2024","journal-title":"Int Breastfeed J."},{"key":"e_1_2_10_9_1","unstructured":"Alimentation des nourrissons pendant leur premi\u00e8re ann\u00e9e de vie. R\u00e9sultats de l'\u00e9tude \u00c9pifane 2021 | Sant\u00e9 publique France (2024). Accessed August 21 2026."},{"key":"e_1_2_10_10_1","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2013-004365","article-title":"Medication use in pregnancy: a cross\u2010sectional, multinational web\u2010based study","volume":"4","author":"Lupattelli A.","year":"2014","journal-title":"BMJ Open"},{"key":"e_1_2_10_11_1","unstructured":"CDC.Prescription Medication Use. Breastfeeding special circumstances (2025). Accessed June 11 2026."},{"key":"e_1_2_10_12_1","volume-title":"Hale\u2019s Medications & Mothers\u2019 Milk 2023\u202f: A Manual of Lactational Pharmacology","author":"Hale T.W.","year":"2023"},{"key":"e_1_2_10_13_1","volume-title":"Grossesse et Allaitement, Guide Th\u00e9rapeutique","author":"Ferreira E.","year":"2013"},{"key":"e_1_2_10_14_1","volume-title":"Drugs and Lactation Database (LactMed\u00ae)","author":"National Institute of Child Health and Human Development","year":"2006"},{"key":"e_1_2_10_15_1","doi-asserted-by":"crossref","first-page":"551","DOI":"10.3390\/ijerph21050551","article-title":"Consensus panel recommendations for the pharmacological Management of Breastfeeding Women with postpartum depression","volume":"21","author":"Eleftheriou G.","year":"2024","journal-title":"Int. J. Environ. Res. Public Health"},{"key":"e_1_2_10_16_1","doi-asserted-by":"crossref","first-page":"763","DOI":"10.1016\/j.clp.2026.05.007","article-title":"Balancing the use of medications while breastfeeding","volume":"53","author":"Masotti E.","year":"2026","journal-title":"Clin. Perinatol."},{"key":"e_1_2_10_17_1","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1016\/j.sagf.2024.12.005","article-title":"Suivi des nourrissons expos\u00e9s aux modulateurs de CFTR au cours de la grossesse","volume":"24","author":"Reix P.","year":"2025","journal-title":"Sages\u2010Femmes"},{"key":"e_1_2_10_18_1","doi-asserted-by":"crossref","first-page":"346","DOI":"10.1111\/apa.17432","article-title":"Breastfed infants exposed to lamotrigine faced a low risk of toxic effects","volume":"114","author":"Alvarez I.","year":"2025","journal-title":"Acta Paediatr."},{"key":"e_1_2_10_19_1","doi-asserted-by":"crossref","first-page":"1367","DOI":"10.1001\/jamaneurol.2013.4290","article-title":"Early child development and exposure to antiepileptic drugs prenatally and through breastfeeding: a prospective cohort study on children of women with epilepsy","volume":"70","author":"Veiby G.","year":"2013","journal-title":"JAMA Neurol."},{"key":"e_1_2_10_20_1","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1089\/bfm.2021.0304","article-title":"Magnitude of lamotrigine exposure through breastfeeding","volume":"17","author":"Kohn E.","year":"2022","journal-title":"Breastfeed. Med."},{"key":"e_1_2_10_21_1","doi-asserted-by":"crossref","first-page":"1891","DOI":"10.1111\/apa.16444","article-title":"Lithium use during breastfeeding was safe in healthy full\u2010term infants under strict monitoring","volume":"111","author":"Heinonen E.","year":"2022","journal-title":"Acta Paediatr."}],"container-title":["Clinical Pharmacology & Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70518","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70518","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70518","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T08:42:32Z","timestamp":1791276152000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70518"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,6]]},"references-count":21,"alternative-id":["10.1002\/cpt.70518"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70518","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,6]]},"assertion":[{"value":"2026-06-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"cpt.70518"}}