The Pros And Cons Of Pregnancy Labeling

Pregnancy labeling of drug products provides guidance to health practitioners in prescribing the most beneficial drug, after assessing the risk of such drug therapy, for an intercurrent condition during pregnancy and lactation. However, there is a paucity of safety data on drug use during pregnancy resulting in a lack of detailed and definitive information added to drug labels at the time of approval. Pregnant women take an average of three to five prescription drugs;1,2 and with over six million pregnancies in the United States every year, approximately half (2.8 million) of which are unintended,3 the potential threat to public health is of concern. While these concerns are reasonable, pregnant women still require medications for medical disorders as pregnancy does not eliminate the need for …show more content…
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