The assessment of drug safety for the fetus
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COMMENTARY
The assessment of drug safety for the fetus Eric M. Hecht1,2,3 Received: 31 January 2020 / Revised: 21 August 2020 / Accepted: 24 August 2020 © Springer Nature Switzerland AG 2020
Abstract Long standing concerns regarding the use of medications during pregnancy and their unknown effects on fetal development and child health suggests the need for modified study methods regarding the establishment of drug safety for the fetus. This Current Commentary highlights several pharmacological study method limitations and offers suggestions for the establishment of drug safety for the fetus. For example, extensive phase 1 pharmacology studies are needed to assess the complex pharmacokinetic relationships between mother and fetus in order to determine injurious doses to the fetus throughout pregnancy. In addition, long term randomized clinical trials are needed to assess the effects medications may have on children following exposure during gestation. Keywords Drug related side effects · Fetus · Pharmacology · Pregnancy
Impact on practice • The assumption that medications used in pregnancy have
previously undergone rigorous pharmacological fetal safety testing is wrong. • There are undefined long-term health risks to a developing child following gestational exposure to some medications. • Fetal safety information is possible following the enrollment of pregnant women into phase 1, 2 and 3 clinical trials designed to study the safety of medications. Clinicians should encourage enrollment into such trials. • Long term follow-up data from randomized clinical trials are needed in order to determine that children are not adversely affected from gestational exposure to medications.
* Eric M. Hecht [email protected] 1
Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA
2
Charles E Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA
3
Institute of Etiological Research, 2800 South Ocean Blvd, Boca Raton, FL, USA
Medication usage during pregnancy has increased substantially over the last several decades. For example, 80% of pregnant women in the US, Europe, and Australia, now use at least one medication during pregnancy [1]. In addition, almost 50% of women use 4 or more drugs at some point in their pregnancy [2] with many of these drugs having D or X former FDA classification labels [3]. Over a similar period of time, numerous childhood chronic illnesses have increased including neurodevelopmental delay, autism, asthma, ADHD and autoimmune illnesses. A relationship between these two trends has been suggested [4]. This Current Commentary highlights several methodological limitations regarding the establishment of drug safety for the fetus and suggests needed changes. Less than 10% of all FDA approved drugs obtain direct pharmacological data from pregnant women and their fetus, despite the fact that most drugs pass through the placenta [5, 6]. Instead, what are obtained are animal reproductive toxicity data, which are well know
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