Literature DB >> 28510297

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary.

J Wang1, T Johnson2, L Sahin2, M S Tassinari2, P O Anderson3, T E Baker4, C Bucci-Rechtweg5, G J Burckart6, C D Chambers7, T W Hale4, D Johnson-Lyles2, R M Nelson8, C Nguyen9, D Pica-Branco2, Z Ren10, H Sachs2, J Sauberan11, A Zajicek10, S Ito12, L P Yao2.   

Abstract

This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants.
© 2017, The American Society for Clinical Pharmacology and Therapeutics.

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Year:  2017        PMID: 28510297      PMCID: PMC5591026          DOI: 10.1002/cpt.676

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


  34 in total

Review 1.  At the dawn of a new discovery: the potential of breast milk stem cells.

Authors:  Foteini Hassiotou; Peter E Hartmann
Journal:  Adv Nutr       Date:  2014-11-14       Impact factor: 8.701

Review 2.  Drugs in Breast Milk.

Authors:  Edward R Newton; Thomas W Hale
Journal:  Clin Obstet Gynecol       Date:  2015-12       Impact factor: 2.190

Review 3.  Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today.

Authors:  Oriana M Damas; Amar R Deshpande; Danny J Avalos; Maria T Abreu
Journal:  J Crohns Colitis       Date:  2015-06-30       Impact factor: 9.071

Review 4.  The use of biologic agents in pregnancy and breastfeeding.

Authors:  Sara Horst; Sunanda Kane
Journal:  Gastroenterol Clin North Am       Date:  2014-07-05       Impact factor: 3.806

5.  Prediction of infant drug exposure through breastfeeding: population PK modeling and simulation of fluoxetine exposure.

Authors:  A Panchaud; F Garcia-Bournissen; C Csajka; J H Kristensen; A Taddio; K F Ilett; E J Begg; S Ito
Journal:  Clin Pharmacol Ther       Date:  2011-04-27       Impact factor: 6.875

Review 6.  Skin nonpenetrating sunscreens for cosmetic and pharmaceutical formulations.

Authors:  Elka Touitou; Biana Godin
Journal:  Clin Dermatol       Date:  2008 Jul-Aug       Impact factor: 3.541

Review 7.  Modeling drug passage into human milk.

Authors:  P O Anderson; J B Sauberan
Journal:  Clin Pharmacol Ther       Date:  2016-05-13       Impact factor: 6.875

8.  Contribution of protein binding, lipid partitioning, and asymmetrical transport to drug transfer into milk in mouse versus human.

Authors:  Naoki Ito; Kousei Ito; Hiroki Koshimichi; Akihiro Hisaka; Masashi Honma; Takashi Igarashi; Hiroshi Suzuki
Journal:  Pharm Res       Date:  2013-05-31       Impact factor: 4.200

9.  The transfer of drugs and therapeutics into human breast milk: an update on selected topics.

Authors:  Hari Cheryl Sachs
Journal:  Pediatrics       Date:  2013-08-26       Impact factor: 7.124

10.  Dietary Iodine Sufficiency and Moderate Insufficiency in the Lactating Mother and Nursing Infant: A Computational Perspective.

Authors:  W Fisher; Jian Wang; Nysia I George; Jeffery M Gearhart; Eva D McLanahan
Journal:  PLoS One       Date:  2016-03-01       Impact factor: 3.240

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  13 in total

Review 1.  Drugs in Lactation.

Authors:  Philip O Anderson
Journal:  Pharm Res       Date:  2018-02-06       Impact factor: 4.200

2.  An in vitro human mammary epithelial cell permeability assay to assess drug secretion into breast milk.

Authors:  Tao Zhang; Zachary Applebee; Peng Zou; Zhen Wang; Erika Solano Diaz; Yanyan Li
Journal:  Int J Pharm X       Date:  2022-06-22

Review 3.  Psychoactive drug exposure during breastfeeding: a critical need for preclinical behavioral testing.

Authors:  Irving Zucker
Journal:  Psychopharmacology (Berl)       Date:  2018-03-16       Impact factor: 4.530

Review 4.  Translational opportunities in the prenatal immune environment: Promises and limitations of the maternal immune activation model.

Authors:  Melissa D Bauman; Judy Van de Water
Journal:  Neurobiol Dis       Date:  2020-04-09       Impact factor: 5.996

5.  Social Media Surveillance of Multiple Sclerosis Medications Used During Pregnancy and Breastfeeding: Content Analysis.

Authors:  Bita Rezaallah; David John Lewis; Carrie Pierce; Hans-Florian Zeilhofer; Britt-Isabelle Berg
Journal:  J Med Internet Res       Date:  2019-08-07       Impact factor: 5.428

6.  The pre- and post-authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation.

Authors:  N Ghalandari; R J E M Dolhain; J M W Hazes; C L E Siezen; J W van der Laan; H J M J Crijns; E P van Puijenbroek; C J van der Woude
Journal:  Br J Clin Pharmacol       Date:  2020-01-23       Impact factor: 4.335

7.  Pharmacogenomic Testing In Pediatrics: Navigating The Ethical, Social, And Legal Challenges.

Authors:  Susanne B Haga
Journal:  Pharmgenomics Pers Med       Date:  2019-10-14

8.  Factors influencing the recruitment of lactating women in a clinical trial involving direct oral anticoagulants: a qualitative study.

Authors:  Yating Zhao; Amally Ding; Roopen Arya; Jignesh P Patel
Journal:  Int J Clin Pharm       Date:  2018-10-10

Review 9.  Review article: direct-acting antivirals for the treatment of HCV during pregnancy and lactation - implications for maternal dosing, foetal exposure, and safety for mother and child.

Authors:  Jolien J M Freriksen; Minou van Seyen; Ali Judd; Diana M Gibb; Intira J Collins; Rick Greupink; Frans G M Russel; Joost P H Drenth; Angela Colbers; David M Burger
Journal:  Aliment Pharmacol Ther       Date:  2019-08-25       Impact factor: 8.171

10.  Minimal breast milk transfer of rituximab, a monoclonal antibody used in neurological conditions.

Authors:  Kristen M Krysko; Sara C LaHue; Annika Anderson; Alice Rutatangwa; William Rowles; Ryan D Schubert; Jacqueline Marcus; Claire S Riley; Carolyn Bevan; Thomas W Hale; Riley Bove
Journal:  Neurol Neuroimmunol Neuroinflamm       Date:  2019-11-12
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