A new era begins in risk communication regarding drug use in pregnancy: Changes in FDA pregnancy risk categories
Twenty nine years after the introduction of Pregnancy Risk Categories, U.S. Food and Drug Administration (FDA) concluded that categories were not successful at conveying the possible risks of drug use in pregnancy. FDA announced its second generation approach to labeling drugs for use in pregnancy and lactation with the publication of Proposed Rule for Pregnancy and Lactation Labeling for Human Prescription Drug and Biological Products on May 29, 2008. The proposed rule is designed as a narrative text containing elements such as fetal risk summary, clinical considerations and data. This manuscript aims to increase information and awareness of family practitioners on this subject.