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

Cavadino, Alana (författare)
Univ Auckland, Sch Populat Hlth, Auckland, New Zealand.
Sandberg, Lovisa (författare)
Uppsala Monitoring Ctr, Uppsala, Sweden.
Ohman, Inger (författare)
Uppsala Monitoring Ctr, Uppsala, Sweden.
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Bergvall, Tomas (författare)
Uppsala Monitoring Ctr, Uppsala, Sweden.
Star, Kristina, 1963- (författare)
Uppsala universitet,Hälso- och sjukvårdsforskning,Uppsala Monitoring Ctr, Uppsala, Sweden.
Dolk, Helen (författare)
Ulster Univ, Inst Nursing & Hlth Res, Newtownabbey, North Ireland.
Loane, Maria (författare)
Ulster Univ, Inst Nursing & Hlth Res, Newtownabbey, North Ireland.
Addor, Marie-Claude (författare)
Univ Hosp Ctr CHUV, Dept Woman Mother Child, CH-1011 Lausanne, Switzerland.
Barisic, Ingeborg (författare)
Univ Zagreb, Childrens Hosp Zagreb, Ctr Excellence Reprod & Regenerat Med, Med Sch, Zagreb, Croatia.
Cavero-Carbonell, Clara (författare)
Fdn Promot Hlth & Biomed Res Valencian Reg, Rare Dis Res Unit, Valencia, Spain.
Garne, Ester (författare)
Hosp Lillebaelt, Paediat Dept, Kolding, Denmark.
Gatt, Miriam (författare)
Directorate Hlth Informat & Res, Malta Congenital Anomalies Registry, Tal Pieta, Malta.
Khoshnood, Babak (författare)
Ctr Biost & Epidemiol, Paris Registry Congenital Malformat, Obstetr Perinatal & Paediat Epidemiol Res Team, INSERM,UMR 1153, Paris, France.
Klungsoyr, Kari (författare)
Univ Bergen, Dept Global Publ Hlth & Primary Care, Bergen, Norway.
Latos-Bielenska, Anna (författare)
Poznan Univ Med Sci, Dept Med Genet, Poznan, Poland.
Lelong, Nathalie (författare)
Ctr Biost & Epidemiol, Paris Registry Congenital Malformat, Obstetr Perinatal & Paediat Epidemiol Res Team, INSERM,UMR 1153, Paris, France.
Lutke, Renee (författare)
Univ Groningen, Univ Med Ctr Groningen, Dept Genet, Groningen, Netherlands.
Materna-Kiryluk, Anna (författare)
Poznan Univ Med Sci, Dept Med Genet, Poznan, Poland.
Nelen, Vera (författare)
PIH, Dept Environm, Antwerp, Belgium.
Nevill, Amanda (författare)
Univ Ferrara, Azienda Osped, Ctr Clin & Epidemiol Res, IMER Registry Emila Romagna Registry Birth Defect, Ferrara, Italy.
O'Mahony, Mary (författare)
Hlth Serv Execut South, Dept Publ Hlth, Cork, Ireland.
Mokoroa, Olatz (författare)
Basque Govt, Dept Hlth, Publ Hlth Div Gipuzkoa, Donostia San Sebastian, Spain.
Pierini, Anna (författare)
CNR, Fdn Toscana Gabriele Monasterio, Inst Clin Physiol, Tuscany Registry Congenital Defects RTDC, Pisa, Italy.
Randrianaivo, Hanitra (författare)
Univ La Reunion St Pierre, REMACOR Med Sch, Unit Congenital Malformat, St Clotilde, Reunion, France.
Rissmann, Anke (författare)
Otto von Guericke Univ, Med Fac, Malformat Monitoring Ctr Saxony Anhalt, Magdeburg, Germany.
Tucker, David (författare)
Singleton Hosp, Publ Hlth Wales Knowledge Directorate, Congenital Anomaly Register & Informat Serv Wales, Level 3,West Wing Block,Sketty Lane, Swansea, W Glam, Wales.
Wiesel, Awi (författare)
Univ Med Ctr Mainz, Dept Pediat, Birth Registry Mainz Model, Mainz, Germany.
Yevtushok, Lyubov (författare)
OMNI Net Ukraine Birth Defects Program, Rivne, Ukraine.;Rivne Reg Med Diagnost Ctr, Rivne, Ukraine.
Morris, Joan K. (författare)
St Georges Univ London, Populat Hlth Res Inst, London, England.
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Univ Auckland, Sch Populat Hlth, Auckland, New Zealand Uppsala Monitoring Ctr, Uppsala, Sweden. (creator_code:org_t)
2021-05-09
2021
Engelska.
Ingår i: Drug Safety. - : ADIS INT LTD. - 0114-5916 .- 1179-1942. ; 44:7, s. 765-785
Relaterad länk:
https://pure.rug.nl/...
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https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Introduction 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. Aims 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. Methods 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. Results 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. Conclusion 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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)

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