gynecology and obstetrics
Drug Safety in Pregnancy
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The FDA's Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling: This document discusses the change in labeling for pregnancy, which eliminates the pregnancy categories (A, B, C, D, X) and replaces them with more helpful and detailed information. The new labeling requires a summary of the risks of drug use during pregnancy and lactation, data to support that summary, and relevant information to help health care professionals make prescribing decisions and advise women about drug use during pregnancy and lactation. Teratogen Information System: This web site provides resources to help clinicians determine the risks of drugs (and of environmental exposures [eg, vaccines, infections]) during pregnancy. It provides expert information about > 1700 drugs (including 200 of the most frequently prescribed drugs). Clinical and experimental literature is summarized, and based on that information, teratogenic risk is assigned. A subscription is required. 