Skip header and navigation

Refine By

1 records – page 1 of 1.

Drug safety: Pregnancy rating classifications and controversies.

https://arctichealth.org/en/permalink/ahliterature282320
Source
Clin Dermatol. 2016 May-Jun;34(3):401-9
Publication Type
Article
Author
Erin Wilmer
Sandy Chai
George Kroumpouzos
Source
Clin Dermatol. 2016 May-Jun;34(3):401-9
Language
English
Publication Type
Article
Keywords
Adrenal Cortex Hormones - adverse effects
Anti-Infective Agents - adverse effects - contraindications
Australia
Biological Products - adverse effects - contraindications
Drug Labeling - legislation & jurisprudence
Drug-Related Side Effects and Adverse Reactions
Evidence-Based Medicine
Female
Humans
Immunosuppressive Agents - adverse effects
Lactation
Pharmaceutical Preparations - classification - contraindications
Pregnancy
Pregnancy Complications - drug therapy
Retinoids - adverse effects - contraindications
Skin Diseases - drug therapy
Sweden
United States
United States Food and Drug Administration
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.
PubMed ID
27265079 View in PubMed
Less detail