Most prescribers and users of drugs are familiar with the precautions
given concerning drug use during the first trimester of pregnancy.
These warnings were introduced after the thalidomide disaster in the
early 1960s. However, limiting the exercise of caution to the first
3 months of pregnancy is both shortsighted and effectively impossible
– first, because chemicals can affect any stage of pre- or postnatal
development; and secondly, because when a woman first learns that
she is pregnant, the process of organogenesis has already long since
begun (for example, the neural tube has closed). Hence, the unborn
could already be inadvertently exposed to maternal drug treatment
during the early embryonic period (Figure 1.1).
This book is intended for practicing clinicians, who prescribe
medicinal products, to evaluate environmental or occupational exposures
in women who are or may become pregnant. Understanding the
risks of drug use in pregnancy has lagged behind the advances in
other areas of pharmacotherapy. Epidemiologic difficulties in establishing
causality and the ethical barriers to randomized clinical trials
with pregnant women are the major reasons for our collective deficiencies.
Nevertheless, since the recognition of prenatal vulnerability
in the early 1960s, much has been accomplished to identify potential
developmental toxicants such as medicinal products and to regulate
human exposure to them. The adverse developmental effects of pharmaceutical
products are now recognized to include not only malformations,
but also growth restriction, fetal death and functional
defects in the newborn
Author: Christof Schaefer, Paul Peters, and Richard K. Miller