The new FDA pregnancy labeling requirements for drugs.

The new US Food and Drug Administration Proposed Rules for pharmaceutical products for the special population of pregnant women were published in May 2008. With these new rules in place, clinicians caring for women who are pregnant may begin to have clearer and more relevant information in the product label to guide clinical decisions regarding drug use during pregnancy.

Cesarean scar dehiscence as a cause of hemorrhage after second-trimester abortion by dilation and evacuation.

Women who have had a cesarean section have a risk of uterine rupture when undergoing a second-trimester pregnancy termination. Beyond the first trimester, uterine rupture has been associated with the use of labor-induction agents and, less often, a placenta accreta. Scar dehiscence, a less disruptive form of scar separation, has not been reported with dilation and evacuation abortion.

The drug development process and the pregnant woman.

The drug development process in the United States includes extensive pre-clinical testing and a series of clinical trials designed to explore the safety and efficacy of a new drug entity. As part of this process, animal studies are conducted to assess the effects of the new drug on the reproductive process. These studies, called developmental and reproductive toxicology studies, form the basis for the information included in the current pregnancy subsection of the drug label.