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Drugs for Pregnant and Lactating Women
The study of medication use in pregnancy is one of the least developed and most neglected areas of clinical pharmacology and drug research. Although pregnancy is widely regarded as a special population due to both the unique maternal physiology and the vulnerability of the developing fetus, researchers and pharmaceutical companies have been reticent to evaluate optimal modalities of treatment for this group. The issue is compounded by the enormous number of medications women are exposed to during pregnancy. Epidemiological surveys indicate nearly two thirds of all pregnant women use four to five drugs during pregnancy throught delivery. Women with medical conditions such as epilepsy, diabetes, and hypertension must continue therapy while pregnant. In some cases, due to a justified or unjustified concern for the developing fetus, the medication prescribed is either withheld, inadequate to treat the maternal condition, or not monitored closely enough as pregnancy progresses for needed adjusments in dosing. The result is a double negative, that of fetal exposure without maternal of fetal benefit. The lack of Food and Drug Administration obstetric labeling and the near universal off-label use of drugs are the direct results of the paucity of research and clinical trials in this special population. The public concern stems from the use of drugs in pregnancy based on an empiric approach rather than a scientific basis, and does not take into account the many alterations in pregnancy.
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