Signal Detection in EUROmediCAT: Identification and Evaluation of Medication–Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference

Autor: Anna Pierini, Ester Garne, Vera Nelen, Anna Materna-Kiryluk, Clara Cavero-Carbonell, Maria Loane, Kari Klungsøyr, Anke Rissmann, Nathalie Lelong, Babak Khoshnood, Joan K Morris, Helen Dolk, Awi Wiesel, Amanda Nevill, Inger Öhman, Tomas Bergvall, Mary O'Mahony, Ingeborg Barišić, Reneé Lutke, David Tucker, Lyubov Yevtushok, Alana Cavadino, Miriam Gatt, Anna Latos-Bielenska, Hanitra Randrianaivo, Olatz Mokoroa, Lovisa Sandberg, Kristina Star, Marie-Claude Addor
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Drug Safety, 44(7), 765-785. ADIS INT LTD
Drug Safety
r-FISABIO. Repositorio Institucional de Producción Científica
instname
r-FISABIO: Repositorio Institucional de Producción Científica
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Cavadino, A, Sandberg, L, Öhman, I, Bergvall, T, Star, K, Dolk, H, Loane, M, Addor, M C, Barisic, I, Cavero-Carbonell, C, Garne, E, Gatt, M, Khoshnood, B, Klungsøyr, K, Latos-Bielenska, A, Lelong, N, Lutke, R, Materna-Kiryluk, A, Nelen, V, Nevill, A, O’Mahony, M, Mokoroa, O, Pierini, A, Randrianaivo, H, Rissmann, A, Tucker, D, Wiesel, A, Yevtushok, L & Morris, J K 2021, ' Signal Detection in EUROmediCAT : Identification and Evaluation of Medication–Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference ', Drug Safety, vol. 44, no. 7, pp. 765-785 . https://doi.org/10.1007/s40264-021-01073-z
ISSN: 0114-5916
Popis: Introduction\ud Knowledge on the safety of medication use during pregnancy is often sparse. Pregnant women are generally excluded from clinical trials, and there is a dependence on post-marketing surveillance to identify teratogenic medications.\ud \ud Aims\ud This study aimed to identify signals of potentially teratogenic medications using EUROmediCAT registry data on medication exposure in pregnancies with a congenital anomaly, and to investigate the use of VigiBase reports of adverse events of medications in the evaluation of these signals.\ud \ud Methods\ud Signals of medication–congenital anomaly associations were identified in EUROmediCAT (21,636 congenital anomaly cases with 32,619 medication exposures), then investigated in a subset of VigiBase (45,749 cases and 165,121 exposures), by reviewing statistical reporting patterns and VigiBase case reports. Evidence from the literature and quantitative and qualitative aspects of both datasets were considered before recommending signals as warranting further independent investigation.\ud \ud Results\ud EUROmediCAT analysis identified 49 signals of medication–congenital anomaly associations. Incorporating investigation in VigiBase and the literature, these were categorised as follows: four non-specific medications; 11 likely due to maternal disease; 11 well-established teratogens; two reviewed in previous EUROmediCAT studies with limited additional evidence; and 13 with insufficient basis for recommending follow-up. Independent investigations are recommended for eight signals: pregnen (4) derivatives with limb reduction; nitrofuran derivatives with cleft palate and patent ductus arteriosus; salicylic acid and derivatives with atresia or stenosis of other parts of the small intestine and tetralogy of Fallot; carbamazepine with atrioventricular septal defect and severe congenital heart defect; and selective beta-2-adrenoreceptor agonists with posterior urethral valve and/or prune belly.\ud \ud Conclusion\ud EUROmediCAT data should continue to be used for signal detection, accompanied by information from VigiBase and review of the existing literature to prioritise signals for further independent evaluation.
Databáze: OpenAIRE
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