Format

Send to

Choose Destination
Clin Dermatol. 2016 May-Jun;34(3):401-9. doi: 10.1016/j.clindermatol.2016.02.013. Epub 2016 Feb 9.

Drug safety: Pregnancy rating classifications and controversies.

Author information

1
Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
2
Department of Dermatology, Warren Alpert Medical School of Brown University, Providence, Rhode Island. Electronic address: Gk@gkderm.com.

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.

[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center