Embryo Project Encyclopedia Articles

In 2014, the United States Food and Drug Administration published the Pregnancy and Lactation Labeling Rule to amend previous guidelines for the prescription of drugs for pregnant and lactating women. The 2014 Pregnancy and Lactation Labeling Rule was intended to increase the safety and efficacy of prescription drugs by making drug labels easier for physicians to understand and utilize. The Pregnancy and Lactation Labeling Rule restructured drug labels and required that they include narratives describing drug-associated risks to women and fetuses, rather than using complicated letter categories. The Pregnancy and Lactation Labeling Rule changed the framework for drug labeling, making it easier for doctors to prescribe safe and effective drugs to pregnant women, lactating women, and people of reproductive capacity.

In 2006, the United States Food and Drug Administration, or FDA, published the “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” also called the Physician Labeling Rule, to improve the safety and efficacy of prescription drugs and drug products. Within the Physician Labeling Rule, the FDA includes a section titled “Use in Specific Populations” or Section 8, which refers to drugs used by pregnant women, lactating women, and people of reproductive capacity. The FDA stated that the purpose of the Physician Labeling Rule was to make drug labels easier for physicians to understand and use when prescribing drugs to pregnant women. With the Physician Labeling Rule, the FDA improved patient-physician communication and the safety of drug use during pregnancy.

Jesse Bennett, sometimes spelled Bennet, practiced medicine in the US during the late eighteenth century and performed one of the first successful cesarean operations, later called cesarean sections, in 1794. Following complications during his wife’s childbirth, Bennett made an incision through her lower abdomen and uterus to deliver their infant. Bennett’s biographers report that his operation was the first cesarean section where both the pregnant woman and the infant survived. Previously, physicians used cesarean sections to save the fetus from a pregnant woman who had already died during childbirth. Bennett successfully performed a cesarean section, a procedure used worldwide in the twenty-first century when a vaginal delivery is not possible or would pose a risk to the woman or fetus.