Sofia Colaceci1, Angela Giusti2, Elise Merrill Chapin3, Micaela Notarangelo4, Alessia De Angelis1, Ercole Vellone1, Rosaria Alvaro1. 1. 1 Department of Biomedicine and Prevention, University of Rome Tor Vergata , Rome, Italy . 2. 2 National Center of Epidemiology, Surveillance, and Health Promotion, National Institute of Health , Rome, Italy . 3. 3 Baby Friendly Initiatives Italian National Committee for UNICEF , Rome, Italy . 4. 4 Private Lactation Consultant Practice , Lerici, La Spezia, Italy .
Abstract
INTRODUCTION: The lack of consistent official information on the use of medications during lactation is probably one of the main reasons leading to an excess of prudence, based on presumption of risk rather than on evidence. The objective of this study was to compare the level of agreement between different official sources available to doctors and women on the use of medications during lactation. MATERIALS AND METHODS: Sources of information included governmental regulatory agencies (RAs) and scientific sources (SS). The package leaflets (PLs) and summaries of product characteristics (SPCs) were retrieved from online databases of the European Union and U.S. RAs. Among the SS, the latest edition of the book Medications and Mothers' Milk by Hale and Rowe and the LactMed database were selected. Information about the use of 11 antihypertensive medications during breastfeeding was analyzed. RESULTS: The PLs and SPCs report a higher risk profile than the one expressed by SS, and they often suggest the interruption of lactation even for compatible medications. CONCLUSIONS: Health professionals should be supported by official, accurate, comprehensive, and consistent information about maternally ingested medication and breastfeeding management to facilitate proper decision-making.
INTRODUCTION: The lack of consistent official information on the use of medications during lactation is probably one of the main reasons leading to an excess of prudence, based on presumption of risk rather than on evidence. The objective of this study was to compare the level of agreement between different official sources available to doctors and women on the use of medications during lactation. MATERIALS AND METHODS: Sources of information included governmental regulatory agencies (RAs) and scientific sources (SS). The package leaflets (PLs) and summaries of product characteristics (SPCs) were retrieved from online databases of the European Union and U.S. RAs. Among the SS, the latest edition of the book Medications and Mothers' Milk by Hale and Rowe and the LactMed database were selected. Information about the use of 11 antihypertensive medications during breastfeeding was analyzed. RESULTS: The PLs and SPCs report a higher risk profile than the one expressed by SS, and they often suggest the interruption of lactation even for compatible medications. CONCLUSIONS: Health professionals should be supported by official, accurate, comprehensive, and consistent information about maternally ingested medication and breastfeeding management to facilitate proper decision-making.
Authors: Brian T Bateman; Sonia Hernandez-Diaz; Krista F Huybrechts; Kristin Palmsten; Helen Mogun; Jeffrey L Ecker; Michael A Fischer Journal: Hypertension Date: 2012-09-10 Impact factor: 10.190
Authors: J Wang; T Johnson; L Sahin; M S Tassinari; P O Anderson; T E Baker; C Bucci-Rechtweg; G J Burckart; C D Chambers; T W Hale; D Johnson-Lyles; R M Nelson; C Nguyen; D Pica-Branco; Z Ren; H Sachs; J Sauberan; A Zajicek; S Ito; L P Yao Journal: Clin Pharmacol Ther Date: 2017-06 Impact factor: 6.875