Talk:USA Drug Categories

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Links: Abnormal Development - Drugs | Australian Fetal Risk Categories | USA FDA Fetal Risk Categories | Therapeutic Goods Authority | Australian Drug Evaluation Committee (ADEC) | Prescribing Medicines in Pregnancy | Appendix A: Therapeutic goods exempted from pregnancy classification |


Drug labeling in the practice of obstetric anesthesia

Am J Obstet Gynecol. 2014 May 2. pii: S0002-9378(14)00436-0. doi: 10.1016/j.ajog.2014.04.040. [Epub ahead of print]

Carvalho B1, Wong CA2.


This commentary outlines the current drug labeling practices that potentially compromise the clinical care of pregnant women and their children. We highlight the need for drug manufacturers and lawmakers to change the status quo and consider practices and regulations that will provide much-needed guidance to clinicians on the safe administration of drugs to certain populations such as pregnant and nursing women. Current practices have de facto contributed to a situation in which evidence is inadequate for individual physicians and patients to weigh the risks and benefits of drug administration and make informed decisions for drug use during pregnancy and lactation. Copyright © 2014 Mosby, Inc. All rights reserved. KEYWORDS: clinical care; drug labeling practices; pregnant women and children

PMID 24799312

Recent changes in pregnancy and lactation labeling: retirement of risk categories

Pharmacotherapy. 2014 Apr;34(4):389-95. doi: 10.1002/phar.1385. Epub 2014 Jan 4.

Ramoz LL1, Patel-Shori NM.

Abstract The rapid development and increased availability of novel pharmacologic therapies and pharmaceutical products has amplified the potential for drug exposure during pregnancy. Many drugs are beneficial for disease state management during pregnancy and provide significant fetal and maternal health benefits. However, a paucity of safety data combined with the imprecision of the current risk category system renders risk versus benefit assessment difficult. In response to decades of criticism, the U.S. Food and Drug Administration (FDA) is implementing a new pregnancy and lactation labeling rule designed to improve risk versus benefit assessment of drugs used in pregnant and nursing mothers. These recommendations will provide clear and detailed information for both patients and health care providers, and they will include three main categories: risk summary, clinical considerations, and data. The new labeling rules remove the previous letter risk categorization system (A, B, C, D, X). In this review, we summarize the upcoming FDA labeling changes and discuss their potential consequences on clinical practice. © 2014 Pharmacotherapy Publications, Inc. KEYWORDS: FDA; U.S. Food and Drug Administration; labeling; lactation; pregnancy; risk categories PMID 24390829