Drug safety: Pregnancy rating classifications and controversies

被引：22

作者：

Wilmer, Erin ^{[1
]}

Chai, Sandy ^{[1
]}

Kroumpouzos, George ^{[1
]}

机构：

[1] Brown Univ, Dept Dermatol, Warren Alpert Med Sch, Providence, RI 02912 USA

来源：

CLINICS IN DERMATOLOGY | 2016年 / 34卷 / 03期

关键词：

SYSTEMIC-LUPUS-ERYTHEMATOSUS; TOPICAL CORTICOSTEROIDS; RHEUMATOID-ARTHRITIS; RISK CLASSIFICATION; MATERNAL EXPOSURE; OCULAR TOXICITY; HYDROXYCHLOROQUINE; OUTCOMES; WOMEN; INFORMATION;

D O I：

10.1016/j.clindermatol.2016.02.013

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

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. (C) 2016 Elsevier Inc. All rights reserved.

引用

页码：401 / 409

页数：9

共 60 条

[1] Hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis and its safety in pregnancy [J].

Abarientos, Crispin ;

Sperber, Kirk ;

Shapiro, Deborah L. ;

Aronow, Wilbert S. ;

Chao, Chun Peng ;

Ash, Julia Y. .

EXPERT OPINION ON DRUG SAFETY, 2011, 10 (05) :705-714

[2] Evolving Knowledge of the Teratogenicity of Medications in Human Pregnancy [J].

Adam, Margaret P. ;

Polifka, Janine E. ;

Friedman, J. M. .

AMERICAN JOURNAL OF MEDICAL GENETICS PART C-SEMINARS IN MEDICAL GENETICS, 2011, 157C (03) :175-182

[3] Risk classification systems for drug use during pregnancy - Are they a reliable source of information? [J].

Addis, A ;

Sharabi, S ;

Bonati, M .

DRUG SAFETY, 2000, 23 (03) :245-253

[4] Use of intravenous immunoglobulin therapy during pregnancy in patients with pemphigus vulgaris [J].

Ahmed, A. R. ;

Guercan, H. M. .

JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2011, 25 (09) :1073-1079

[5]

[Anonymous], 1994, TERATOLOGY, V49, P446

[6]

[Anonymous], 2008, FED REGISTER, V73, P30831

[7]

Australian Government Dept of Health, 2014, AUSTR CAT SYST PRESC

[8] Anophthalmia and agenesis of optic chiasma associated with adapalene gel in early pregnancy [J].

Autret, E ;

Berjot, M ;

JonvilleBera, AP ;

Aubry, MC ;

Moraine, C .

LANCET, 1997, 350 (9074) :339-339

[9] Management of psoriasis in pregnancy [J].

Babalola, Olubukola ;

Strober, Bruce E. .

DERMATOLOGIC THERAPY, 2013, 26 (04) :285-292

[10] Evaluation and management of systemic lupus erythematosus and rheumatoid arthritis during pregnancy [J].

Barbhaiya, Medha ;

Bermas, Bonnie L. .

CLINICAL IMMUNOLOGY, 2013, 149 (02) :225-235

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