Studies of Drug‐Induced Birth Defects

Individual‐based versus aggregate meta‐analysis in multi‐database studies of pregnancy outcomes: the Nordic example of selective serotonin reuptake inhibitors and venlafaxine in pregnancy

“…An important concern specific to teratogenesis is that one cannot assume that if a specific substance is a teratogen, all other substances within the same drug class are also teratogens. 17 Because both specific birth defects and in-utero exposure to particular substances in general are very rare occurrences, "big data" studies may be necessary to yield definitive conclusions about teratogenicity of that specific substance, rather than of the drug class. For RVOTO, country-specific adjusted analyses were not considered feasible at the substance level because of sparse data and countries with no exposed cases.…”

Research challenges for drug‐induced birth defects

“…Oliveira et al 4 analyzed the birth prevalence of microcephaly in Brazil through the Live Birth Certificate notification, and observed a sharp increase in the number of microcephaly cases during 2015-2016. They identified temporal and geospatial correlation between the occurrence of maternal febrile rash illness and the emergence of microcephaly in the offspring.…”

“…We thus must rely on postmarketing epidemiologic studies, each design having its own strengths and limitations, 4 but what kinds of studies provide the required information? Pregnancy registries, which recruit pregnant women exposed to a drug of interest and follow them to identify birth defects (and other outcomes) among their offspring, typically enroll a few hundred to perhaps 1,000 or so subjects.…”

Influenza vaccine safety in pregnancy: can we identify exposures?

“…Complicating this situation, we know from experience that neither animal studies nor pharmacologic understanding reliably predict the likelihood of birth defects (teratogenesis) and other adverse fetal outcomes resulting from exposures in the pregnant woman. 1 Thus, for most pharmaceutical agents, evaluation of possible teratogenesis can only occur in the postmarketing setting.…”