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Downloaded from http://journals.lww.com/adversedrugreactbull by BhDMf5ePHKbH4TTImqenVJ2toCr/9wZZjwPUWvYES9l2nY+zyylnl33NGMK6MRsx on 10/02/2020 April 2020 No. 321 Founded in 1966 by Professor D M Davies, FRCP, FRCP Ed ISSN 0044–6394 Risk assessment Assessing the fetal risk of a drug causing malformation is complicated by the fact that a,b c Jon T. Andersen & Tina Bergmann Futtrup the background risk of a child being born Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg, with a major congenital malformation is Institute of Clinical Medicine, Faculty of Medical and Health Science, University of 3.5%, and most often without a known Copenhagen, Copenhagen and Department of Obstetrics and Gynecology, Copenhagen cause. Based on this, it can be statistically University Hospital North Zealand, Hillerød, Denmark estimated that 200 pregnancies exposed to a Correspondence to Jon T. Andersen, MD, PhD, chief physician, associated professor, drug during the 1st trimester provide enough Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg, power (80% strength and 5% significance Bispebjerg Bakke 23, DK-2400 Copenhagen, Denmark. Tel.: +45 2972 1508; level) to exclude an increased risk of more e-mail: jon.thor.traerup.andersen@regionh.dk than three times higher than the background risk; 700 exposed provide enough power (80% strength and 5% significance level) to exclude an increased risk of more
Adverse Drug Reaction Bulletin – Wolters Kluwer Health
Published: Apr 1, 2020
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