However, the extrapolation of these data to humans is often uncertain.4,5 Hence, the risk/benefit profile of many medications on pregnancy are not established at the time of introduction into the market thus, emphasizing the need for more human data on the use of medications during pregnancy. Pregnant women are usually excluded from clinical trials, for ethical reasons, consequently requiring the collection of most safety information on drug use during pregnancy in the post-approval period. Published cases reports and passive surveillance of pregnancy outcomes as executed in the FDA’s Adverse Event Reporting System (FAERS) may signal potential drug safety issues, but these data are inherently limited in their relevance.6-9 On the other hand, retrospective and prospective observational studies including, pregnancy registries which have post-marketing data requirements and set-up rules as issued by the FDA and the European Medicines Agency (EMA),10-12 are effective in identifying an association between a specific drug therapy and an adverse
However, the extrapolation of these data to humans is often uncertain.4,5 Hence, the risk/benefit profile of many medications on pregnancy are not established at the time of introduction into the market thus, emphasizing the need for more human data on the use of medications during pregnancy. Pregnant women are usually excluded from clinical trials, for ethical reasons, consequently requiring the collection of most safety information on drug use during pregnancy in the post-approval period. Published cases reports and passive surveillance of pregnancy outcomes as executed in the FDA’s Adverse Event Reporting System (FAERS) may signal potential drug safety issues, but these data are inherently limited in their relevance.6-9 On the other hand, retrospective and prospective observational studies including, pregnancy registries which have post-marketing data requirements and set-up rules as issued by the FDA and the European Medicines Agency (EMA),10-12 are effective in identifying an association between a specific drug therapy and an adverse