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Author: Admin | 2025-04-28
Medications may be required for various indications during pregnancy. The most commonly used medications include antiemetics, antacids, antihistamines, analgesics, antimicrobials, diuretics, antidepressants, and tranquilizers. Substance use and misuse is also common. Despite this trend, firm evidence-based guidelines for safe use of medications during pregnancy are still lacking.Regulatory Information about Drug Safety During PregnancyUntil the 2010s, the U.S. Food and Drug Administration (FDA) classified over-the-counter (OTC) and prescription drugs into 5 categories of safety for use during pregnancy (A, B, C, D, X). However, few well-controlled studies of therapeutic drugs have been done in pregnant women. Most information about drug safety during pregnancy is derived from animal studies, uncontrolled studies, and postmarketing surveillance. Consequently, the FDA classification system led to confusion and difficulty applying available information to clinical decisions. In December 2014, the FDA responded by requiring that the pregnancy categories A, B, C, D, and X be removed from the labeling of all drugs.Instead of categories, the FDA now requires that drug labels provide information about the specific drug in a consistent format (called the final rule, or Pregnancy and Lactation Labeling (Drugs) Final Rule [PLLR]).The information required by the FDA has 3 subsections:Pregnancy: Information relevant to the use of the drug in pregnant women (eg, dosing, fetal risks) and information about whether there is a registry that collects and maintains data on how pregnant women are affected by the drugLactation: Information about using the drug while breastfeeding (eg, the amount of drug in breast milk, potential effects on the breastfed child)Females and males of reproductive potential: Information about pregnancy testing, contraception, and infertility as it relates to the drugThe pregnancy and lactation subsections each include 3 subheadings (risk summary, clinical considerations, and data) that provide more detail. The final rule does not apply to nonprescription (over-the-counter) drugs.Drug Transfer and Metabolism During PregnancyDuring pregnancy, medications are often required to treat certain disorders. In general, when potential benefit outweighs known risks, medications may be considered for treatment of disorders during pregnancy.Not all medications or other substances in the maternal circulation cross the placenta (transfer) to the fetus. Some drugs that cross the placenta may have a direct toxic effect or a teratogenic effect. Drugs that do not cross the placenta may still harm the fetus by Constricting placental vessels and thus impairing gas and nutrient exchangeProducing severe uterine hypertonia that results in anoxic injuryAltering maternal physiology (eg, causing hypotension)For a list
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