①
异维A酸是常见的治疗痤疮的药物，但是胎儿暴露于其具有流产和畸形的风险，所以美国自2006年来开展iPLEDGE项目，旨在减少胎儿异维A酸暴露；
②
美国自1997年到2017年，共报告6740例异维A酸暴露的妊娠孕妇，其中2006年达到高峰；
③
2011年后该人群控制在200-300例/年左右；
④
异维A酸暴露的育龄期女性怀孕率在0.33-0.65%之间；
⑤
2006年后，异维A酸暴露相关的怀孕、流产、胎儿畸形发生率均降低，但仍然存在，需要继续防控。
US Food and Drug Administration reports of pregnancy and pregnancy-related adverse events associated with isotretinoin
美国食品药品监督管理局关于异维A酸服用相关的妊娠及其妊娠结局的报告
10.1001/jamadermatol.2019.1388
2019-07-17, Article
Abstract & Authors:
展开
Abstract:
收起
Importance :
iPLEDGE is a rigorous program initiated in 2006 to reduce fetal exposure to isotretinoin, a disease-modifying medication for acne that carries a risk of teratogenesis. Despite the imposition of iPLEDGE requirements on patients and clinicians, the scope of isotretinoin-related adverse events is unknown.
Objective :
To determine the frequency and rate of pregnancy and pregnancy-related adverse events among women taking isotretinoin reported to the US Food and Drug Administration (FDA).
Design, Setting, and Participants:
Pregnancy reports from the FDA Adverse Event Reporting System, a public database of medication adverse event reports filed by prescribers, consumers, and manufacturers, were used to perform a retrospective analysis of pregnancy-related adverse events associated with isotretinoin from January 1, 1997, to December 31, 2017. Each individual reporting any pregnancy-related adverse event signified 1 pregnancy. Abortions, pregnancies that occurred while contraception was used, and fetal defects were counted as subgroups of total pregnancy events.
Main Outcomes and Measures:
The frequency of pregnancy and of pregnancy-related events (abortions, pregnancies that occurred while using contraception, and fetal defects) were stratified by year that the FDA was notified of the event and by age. The rates of adverse events were calculated using isotretinoin prescribing data.
Results :
There was a total of 6740 pregnancies among women taking isotretinoin reported to the FDA from 1997 to 2017, peaking in 2006 (768 pregnancies) before settling into a range of 218 to 310 annual reports of pregnancy after 2011. The mean (SD) age of the women was 24.6 (7.1) years. The rate of pregnancy for females of childbearing potential was between 0.33% (388 of 115 925) and 0.65% (768 of 117 784), with a peak in 2006. Although pregnancies, abortions, and fetal defects among women taking isotretinoin have decreased since the initiation of iPLEDGE in 2006, all 3 persist.
Conclusions and Relevance:
The number of reports of pregnancies, abortions, and fetal defects among women taking isotretinoin has decreased since peaking around the initiation of iPLEDGE in 2006. Explanations for this trend include a broader national decrease in teenage pregnancies and abortion rates, improvements in access to effective long-term and emergency contraception, stringent iPLEDGE requirements, and reporting fatigue over time. Despite the decrease, persistent reporting of pregnancy-related events in the last decade warrants investigation into the efficacy of iPLEDGE and exploration of new approaches for lowering fetal exposure to isotretinoin.
First Authors:
Elizabeth Tkachenko
Correspondence Authors:
Arash Mostaghimi
All Authors:
Elizabeth Tkachenko,Sean Singer,Priyank Sharma,John Barbieri,Arash Mostaghimi
一键推荐相关好文章
