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 1907, researchers Bernhardt Kronig and Carl Gauss combined the drugs morphine and scopolamine to induce twilight sleep in women during childbirth. Physicians in the early twentieth century in Germany used twilight sleep, Dammerschlaf, to cause women to enter a state of consciousness in which they felt no pain and did not remember giving birth. Twilight sleep was associated with increased use of forceps during delivery, prolonged labor, and increased risk of infant suffocation. Because of those disadvantages, physicians stopped using morphine and scopolamine to prevent pain during childbirth. Morphine and scopolamine were among the first anesthetics to be used during childbirth, and after physicians stopped using them, researchers searched for safer alternatives.