Availability of Safe and Effective Therapeutic Options to Pregnant and Lactating Individuals Following the United States Food and Drug Administration Pregnancy and Lactation Labeling Rule

被引：2

作者：

Patel, Ashaka ^{[1
]}

Sushko, Katelyn ^{[2
,11
]}

Mazer-Amirshahi, Maryann ^{[3
]}

Fletcher, Elimika Pfuma ^{[4
]}

Fusch, Gerhard ^{[2
]}

Chan, Olsen ^{[2
]}

Aghayi, Arya ^{[5
]}

Chan, Anthony K. C. ^{[6
]}

Lacaze-Masmonteil, Thierry ^{[7
]}

Anker, Johannes Van Den ^{[8
,9
]}

Samiee-Zafarghandy, Samira ^{[10
]}

机构：

[1] Western Univ, Schulich Sch Med & Dent, London, ON, Canada

[2] McMaster Univ, Fac Hlth Sci, Hamilton, ON, Canada

[3] MedStar Washington Hosp Ctr, Dept Emergency Med, Washington, DC USA

[4] FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[5] McGill Univ, Fac Sci, Montreal, PQ, Canada

[6] McMaster Childrens Hosp, Dept Pediat, Div Hematol & Oncol, Hamilton, ON, Canada

[7] Univ Calgary, Dept Pediat, Div Neonatol, Calgary, AB, Canada

[8] Childrens Natl Hlth Syst, Dept Pediat, Div Pediat Clin Pharmacol, Washington, DC USA

[9] Univ Basel, Div Pediat Pharmacol & Pharmacometr, Childrens Hosp, Basel, Switzerland

[10] McMaster Childrens Hosp, Dept Pediat, Div Neonatol, Hamilton, ON, Canada

[11] McMaster Univ, 1280 Main St W, Hamilton, ON L8S 4L8 28, Canada

来源：

JOURNAL OF PEDIATRICS | 2023年 / 259卷

关键词：

ANIMAL-MODELS; ROFLUMILAST; TRIALS;

D O I：

10.1016/j.jpeds.2023.01.016

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

Objective To explore the extent and type of pregnancy and lactation data of newly approved prescription drugs and assess whether the presented recommendations are data-driven, as required by the US Food and Drug Administration Pregnancy and Lactation Labeling Rule implemented in 2015. Study design In this descriptive analysis, we reviewed pregnancy and lactation data of all new molecular entities approved between 2001 and 2020 in their most updated labeling. Information was collected regarding the pregnancy and lactation risk statements, the source of pregnancy and lactation data, and the design and methods of pregnancy and lactation studies in the labeling. Results Of the 422 new molecular entities, the key advisory statement for use of 133 (32%) drugs in pregnancy and 194 (46%) drugs in lactation were classified as "against use." Less than 2% of all drugs had a key advisory statement that supported their use during pregnancy or lactation. The sources of data regarding use in pregnancy were studies in human and animals in 46 (11%) and 348 (82%) drugs, respectively. For use during lactation, data included studies in human and animals in 23 (5%) and 251 (59%) drugs, respectively. The key advisory recommendation was consistent with the available human information in 4 (8%) drugs in pregnancy and 3 (13%) drugs in lactation. Prescription drug labeling contains limited data to support informed decision-making for the use of prescription drugs during pregnancy/lactation. Close collaboration among stakeholders is required to enhance the availability of data in this population.

引用

页码：1 / 11

页数：11

共 1 条

[1] Highlights from the United States Food and Drug Administration's Public Workshop on the Development of Animal Models of Pregnancy to Address Medical Countermeasures in an "At-Risk" Population of Pregnant Women: Influenza as a Case Study
Williams, Denita
Basavarajappay, Mallikarjuna S.
Rasmussen, Sonja A.
Morris, Suzanne
Mattison, Donald
BIRTH DEFECTS RESEARCH PART A-CLINICAL AND MOLECULAR TERATOLOGY, 2014, 100 (10) : 806 - 810

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