Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods:Recommendations from the IMI ConcePTION Project

Autor: Jonathan L. Richardson, Alan Moore, Rebecca L. Bromley, Michael Stellfeld, Yvonne Geissbühler, Matthew Bluett-Duncan, Ursula Winterfeld, Guillaume Favre, Amalia Alexe, Alison M. Oliver, Yrea R. J. van Rijt-Weetink, Kenneth K. Hodson, Bita Rezaallah, Eugene P. van Puijenbroek, David J. Lewis, Laura M. Yates

Publikováno v: Richardson, J L, Moore, A, Bromley, R L, Stellfeld, M, Geissbühler, Y, Bluett-Duncan, M, Winterfeld, U, Favre, G, Alexe, A, Oliver, A M, van Rijt-Weetink, Y R J, Hodson, K K, Rezaallah, B, van Puijenbroek, E P, Lewis, D J & Yates, L M 2023, ' Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods : Recommendations from the IMI ConcePTION Project ', Drug Safety . https://doi.org/10.1007/s40264-023-01291-7

INTRODUCTION AND OBJECTIVE: The risks and benefits of medication use in pregnancy are typically established through post-marketing observational studies. As there is currently no standardised or systematic approach to the post-marketing assessment of

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::69c4bd30c9f9fa284e022ab5e27bbb4f
https://research.manchester.ac.uk/en/publications/526efee3-f4f3-49fd-bc3a-f762e6ad9737

Breastfeeding in children of women taking antiepileptic drugs: Cognitive outcomes at age 6 years

Autor: Kimford J, Meador, Gus A, Baker, Nancy, Browning, Morris J, Cohen, Rebecca L, Bromley, Jill, Clayton-Smith, Laura A, Kalayjian, Andres, Kanner, Joyce D, Liporace, Page B, Pennell, Michael, Privitera, David W, Loring, Thad, Zajdowicz

Publikováno v: Meador, K J, Baker, G A, Browning, N, Cohen, M J, Bromley, R L, Clayton-Smith, J, Kalayjian, L A, Kanner, A, Liporace, J D, Pennell, P B, Privitera, M & Loring, D W 2014, ' Breastfeeding in children of women taking antiepileptic drugs: Cognitive outcomes at age 6 years ', JAMA pediatrics, vol. 168, no. 8, pp. 729-736 . https://doi.org/10.1001/jamapediatrics.2014.118
Meador, K J, Baker, G A, Browning, N, Cohen, M J, Bromley, R L, Clayton-Smith, J, Kalayjian, L A, Kanner, A, Liporace, J D, Pennell, P B, Privitera, M & Loring, D W 2014, ' Breastfeeding in children of women taking antiepileptic drugs: Cognitive outcomes at age 6 years ' JAMA pediatrics, vol. 168, no. 8, pp. 729-736 . https://doi.org/10.1001/jamapediatrics.2014.118

IMPORTANCE Breastfeeding is known to have beneficial effects, but concern exists that breastfeeding during maternal antiepileptic drug (AED) therapymay be harmful.We previously noted no adverse effects of breastfeeding associated with AED use on IQ a

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https://www.research.manchester.ac.uk/portal/en/publications/breastfeeding-in-children-of-women-taking-antiepileptic-drugs-cognitive-outcomes-at-age-6-years(4cc75be3-858d-42ca-bf78-d4b39d1d9978).html

Early cognitive development in children born to women with epilepsy: a prospective report

Autor: Rebecca L, Bromley, George, Mawer, Jenna, Love, James, Kelly, Laura, Purdy, Lauren, McEwan, Maria, Briggs, Jill, Clayton-Smith, Xin, Shi, Xin, Sin, Gus A, Baker, Lynne, Wyatt

Publikováno v: Epilepsia. 51(10)

In this prospective study the early cognitive development of children born to women with epilepsy (n = 198) was assessed and compared to a group of children representative of the general population (n = 230).The children were assessed when younger th

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https://pubmed.ncbi.nlm.nih.gov/20633039