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 |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Heart Defects
Congenital Posterior urethral valve Pediatrics medicine.medical_specialty 1ST TRIMESTER MEDLINE LAMOTRIGINE USE Toxicology 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Ductus arteriosus medicine Humans MALFORMATIONS Pharmacology (medical) Registries 030212 general & internal medicine Adverse effect PRENATAL EXPOSURE Tetralogy of Fallot congenital anomalies drug safety pharmacoepidemiology pharmacovigilance pregnancy RISK Pharmacology Pregnancy DISPROPORTIONALITY business.industry BIRTH-DEFECTS PREVENTION OROFACIAL CLEFT medicine.disease Teratology Clinical trial Pregnancy Trimester First Teratogens PREGNANCY medicine.anatomical_structure Female MATERNAL AGE business |
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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