Abstract
With scores of new medications entering the market every year, the labeling for most of these drugs does not contain safety or efficacy data related to exposure during pregnancy. Yet, millions of pregnant women have disorders that require timely treatment, from chronic conditions such as epilepsy to pregnancy-induced conditions such as nausea and vomiting. The lack of knowledge in regard to maternal effectiveness and fetal safety of medications is a significant challenge for the practitioner, and exposes the mother to risk of insufficient therapy for her condition, and places her unborn baby at a potential risk of toxicity. The major task for the scientific community and regulators is to alter the clinical and policy environment which has left women and their unborn babies as therapeutic orphans. This chapter discusses the key elements of these challenges and offer practical solutions to close the knowledge gap.
Keywords
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReferences
McBride WG. Teratogenic action of thalidomide. Lancet. 1978;1:1362.
Koren G. Treating the mother, protecting the unborn: the motherisk approach. J Pediatr Pharmacol Ther. 2013;18:4–7.
Koren G, Pastuszak A, Ito S. Drugs in pregnancy. N Engl J Med. 1998;338:1128–37.
Heinonen OP, Slone D, Shapiro S, Gaetano LF, Hartz SC, Mitchell AA, et al. Birth defects and drugs in pregnancy. Sedatives, tranquilizers and antidepressant drugs. In: Kaufman DW, editor. Birth Defects and Drugs in Pregnancy. Littleton: Publishing Sciences Group; 1977.
Koren G. Fetal risks of maternal pharmacotherapy: identifying signals. Handb Exp Pharmacol. 2011;205:285–94.
Wilcox AJ, Baird DD, Weinberg CR. Time of implantation of the conceptus and loss of pregnancy. N Engl J Med. 1999;340:1796–9.
Bennett PN. Drugs and human lactation. 2nd ed. Amsterdam: Elsevier; 1996.
Mahadevan U, Kane S, Sandborn WJ, Cohen RD, Hanson K, Terdiman JP, et al. Intentional infliximab use during pregnancy for induction or maintenance of remission in Crohn’s disease. Aliment Pharmacol Ther. 2005;21:733–8.
Mahadevan U, Cucchiara S, Hyams JS, Steinwurz F, Nuti F, Travis SP, et al. The London position statement of the World Congress of Gastroenterology on biological therapy for IBD with the European Crohn’s and Colitis Organisation: pregnancy and pediatrics. Am J Gastroenterol. 2011;106:214–23.
Diav-Citrin O, Shechtman S, Halberstadt Y, Finkel-Pekarsky V, Wajnberg R, Arnon J, et al. Pregnancy outcome after in utero exposure to angiotensin converting enzyme inhibitors or angiotensin receptor blockers. Reprod Toxicol. 2011;31:540–5.
Walfisch A, Al-maawali A, Moretti ME, Nickel C, Koren G. Teratogenicity of angiotensin converting enzyme inhibitors or receptor blockers. J Obstet Gynaecol. 2011;31:465–72.
Guignard JP, Burgener F, Calame A. Persistent anuria in a neonate: a side effect of captopril. Int J Pediatr Nephrol. 1981;2:133.
Al-Maawali A, Walfisch A, Koren G. Taking angiotensin-converting enzyme inhibitors during pregnancy – Is it safe? Can Fam Physician. 2012;58:49–51.
Barr Jr M. Teratogen update: angiotensin-converting enzyme inhibitors. Teratology. 1994;50:399–409.
Bennett HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004;103:698–709.
Engeland A, Bramness JG, Daltveit AK, Ronning M, Skurtveit S, Furu K. Prescription drug use among fathers and mothers before and during pregnancy. A population-based cohort study of 106,000 pregnancies in Norway 2004 Y 2006. Br J Clin Pharmacol. 2008;65:653–60.
Koren G, Nordeng H. Antidepressant use during pregnancy: the benefit-risk ratio. Am J Obstet Gynecol. 2012;207:157–63.
Einarson A, Smart K, Vial T, Diav-Citrin O, Yates L, Stephens S, et al. Rates of major malformations in infants following exposure to duloxetine during pregnancy: a preliminary report. J Clin Psychiatry. 2012;73:1471. doi:10.4088/JCP.12l08013.
Santos RP, Pergolizzi JJ. Transient neonatal jitteriness due to maternal use of sertraline (Zoloft). J Perinatol. 2004;24:392–4.
Reis M, Källén B. Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data. Psychol Med. 2010;40:1723–33.
Einarson A, Choi J, Einarson TR, Koren G. Rates of spontaneous and therapeutic abortions following use of antidepressants in pregnancy: results from a large prospective database. J Obstet Gynaecol Can. 2009;31:452–6.
Nakhai-Pour HR, Broy P, Bérard A. Use of antidepressants during pregnancy and the risk of spontaneous abortion. Can Med Assoc J. 2010;182:1031–7.
Chambers CD, Hernandez-Diaz S, Van Marter LJ, Werler MM, Louik C, Jones KL, et al. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med. 2006;354:579–87.
Moses-Kolko EL, Bogen D, Perel J, Bregar A, Uhl K, Levin B, et al. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors: literature review and implications for clinical applications. JAMA. 2005;293:2372–83.
Kieler H, Artama M, Engeland A, Ericsson O, Furu K, Gissler M, et al. Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: population based cohort study from the five Nordic countries. Br Med J. 2012;344:d8012. doi:10.1136/bmj.d8012.
Koren G, Nordeng H. SSRIs and persistent pulmonary hypertension of the newborn. Br Med J. 2011;344:d7642.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Gadot, Y., Koren, G. (2015). Medications in Pregnancy: Can We Treat the Mother While Protecting the Unborn?. In: MacLeod, S., Hill, S., Koren, G., Rane, A. (eds) Optimizing Treatment for Children in the Developing World. Adis, Cham. https://doi.org/10.1007/978-3-319-15750-4_7
Download citation
DOI: https://doi.org/10.1007/978-3-319-15750-4_7
Publisher Name: Adis, Cham
Print ISBN: 978-3-319-15749-8
Online ISBN: 978-3-319-15750-4
eBook Packages: MedicineMedicine (R0)