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Clin Dermatol ; 34(3): 401-9, 2016.
Article in English | MEDLINE | ID: mdl-27265079

ABSTRACT

This contribution consolidates data on international pregnancy rating classifications, including the former US Food and Drug Administration (FDA), Swedish, and Australian classification systems, as well as the evidence-based medicine system, and discusses discrepancies among them. It reviews the new Pregnancy and Lactation Labeling Rule (PLLR) that replaced the former FDA labeling system with narrative-based labeling requirements. PLLR emphasizes on human data and highlights pregnancy exposure registry information. In this context, the review discusses important data on the safety of most medications used in the management of skin disease in pregnancy. There are also discussions of controversies relevant to the safety of certain dermatologic medications during gestation.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , Pharmaceutical Preparations/classification , Pregnancy Complications/drug therapy , Skin Diseases/drug therapy , Adrenal Cortex Hormones/adverse effects , Anti-Infective Agents/adverse effects , Australia , Biological Products/adverse effects , Contraindications , Drug Labeling/legislation & jurisprudence , Evidence-Based Medicine , Female , Humans , Immunosuppressive Agents/adverse effects , Lactation , Pregnancy , Retinoids/adverse effects , Sweden , United States , United States Food and Drug Administration
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