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Global comment on the use of hydroxychloroquine during the periconception period and pregnancy in women with autoimmune diseases
Karen Schreiber 1 , Ian Giles 2 , Nathalie Costedoat-Chalumeau 3 , Catherine Nelson-Piercy 4 , Radboud Jem Dolhain 5 , Marta Mosca 6 , Frauke Förger 7 , Rebecca Fischer-Betz 8 , Anna Molto 9 , Angela Tincani 10 , Elisabeth Pasquier 11 , Benoit Marin 12 , Elisabeth Elefant 13 , Jane Salmon 14 , Bonnie L Bermas 15 , Lisa Sammaritano 14 , Megan E B Clowse 16 , Christina Chambers 17 , Jill Buyon 18 , Saori Abe Inoue 19 , Nancy Agmon-Levin 20 , Silvia Aguilera 21 , Samar Al Emadi 22 , Jeanette Andersen 23 , Danieli Andrade 24 , Aleksandra Antovic 25 , Laurent Arnaud 26 , Alice Ashouri Christiansen 27 , Tadej Avcin 28 , Sara Badreh-Wirström 29 , George Bertsias 30 , Ilaria Bini 31 , Anca Bobirca 32 , Ware Branch 33 , Antonio Brucato 34 , Irene Bultink 35 , Susanna Capela 36 , Irene Cecchi 37 , Ricard Cervera 38 , Cecilia Chighizola 39 , Claudia Cobilinschi 40 , Maria Jose Cuadrado 41 , Dzifa Dey 42 , Oseme Etomi 4 , Gerard Espinosa 43 , Julia Flint 44 , João-Eurico Fonseca 45 , Ruth Fritsch-Stork 46 , Maria Gerosa 47 , Bente Glintborg 48 , Carina Gøtestam Skorpen 49 , Bethan Goulden 50 , Christine Graversgaard 51 , Iva Gunnarsson 52 , Latika Gupta 53 , Merete Hetland 54 , Ken Hodson 55 , Beverley J Hunt 56 , David Isenberg 2 , Søren Jacobsen 57 , Munther Khamashta 58 , Roger Levy 59 , Louise Linde 60 , Jacob Lykke 61 , Yvette Meissner 62 , Louise Moore 63 , Eric Morand 64 , Sandra Navarra 64 , Daniela Opris-Belinski 65 , Monika Østensen 66 , Hiroki Ozawa 67 , Luis Fernando Perez-Garcia 68 , Michelle Petri 69 , Guillermo J Pons-Estel 70 , Massimo Radin 37 , Luigi Raio 71 , Amihai Rottenstreich 72 , Guillermo Ruiz-Irastorza 73 , Slađana Rumpl Tunjić 74 , Marite Rygg 75 , Savino Sciascia 37 , Anja Strangfeld 76 , Elisabet Svenungsson 77 , Maria Tektonidou 78 , Anne Troldborg 79 , Evelyne Vinet 80 , Jelena Vojinovic 81 , Anne Voss 82 , Marianne Wallenius 83 , Laura Andreoli 84
We would like to express our united concerns about the February, 2023 recommendation by the European Medicines Agency to update the background section of the summary of product characteristics and the patient information leaflet for the use of hydroxychloroquine in pregnancy.1
Previously, the background information on hydroxychloroquine use in pregnancy referenced data in “300–1000 prospective pregnancies from observational studies, as well as a meta-analysis of pregnancy exposure (mainly in women with autoimmune disease)”, at doses ranging from 200 mg to 400 mg, “which did not show a statistically significant increase of congenital malformations or feto/neonatal toxicity related to hydroxychloroquine use in pregnancy.”2
This section will be replaced by text citing only one study by Huybrechts and colleagues3 reporting findings of a small increased risk of congenital malformations with the use of highdose hydroxychloroquine during pregnancy.
CITA DEL ARTÍCULO Lancet Rheumatol. 2023 Sep;5(9):e501-e506. doi: 10.1016/S2665-9913(23)00215-1. Epub 2023 Aug 21
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