Maternal acetaminophen use and childhood cancer

母亲使用对乙酰氨基酚与儿童癌症

基本信息

批准号：
10512922
负责人：
Julia Heck
金额：
$ 7.01万
依托单位：
UNIVERSITY OF NORTH TEXAS
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10512922
关键词：
Acetaminophen Address Adverse effects Affect Aminophenols Analgesic and Antipyretic Anatomy Antibiotics Birth Cancer Etiology Chemicals Child Classification Code Collaborations Communicable Diseases Conceptions Confidence Intervals Cryptorchidism Data Data Sources Databases Diagnosis Diagnostic Diethylstilbestrol Disease Dose Europe Exposure to Fetal Development Fetus Functional disorder Headache Health Hepatoblastoma Hepatotoxicity ICD-9 Injury Intake Link Low Birth Weight Infant Malignant Childhood Neoplasm Malignant Neoplasms Maternal Health Maternal and Child Health Medical Records National Health Insurance Neuroepithelial, Perineurial, and Schwann Cell Neoplasm Neurological outcome Outcome Parents Pharmaceutical Preparations Pharmacoepidemiology Pharmacologic Substance Pharmacy facility Physicians Polypharmacy Population Study Pregnancy Pregnant Women Premature Birth Property Prospective Studies Publishing Recommendation Records Registries Reporting Research Research Design Research Personnel Resources Risk Risk Factors Role Safety Selection Bias Source Spasm Taiwan Testing Therapeutic Time Tylenol United States Food and Drug Administration Vaginal Adenocarcinoma Voice Woman anogenital distance anticancer research autism spectrum disorder base cancer risk carcinogenicity cohort data registry design developmental toxicity early childhood epidemiology study insurance claims interest maternal risk medulloblastoma neoplasm registry offspring population based prenatal exposure prospective

项目摘要

Project summary Approximately 65% of US pregnant women take acetaminophen (in the US, branded as Tylenol; in Europe, paracetamol). Despite increasing concerns for its safety in pregnancy, with reported liver and developmental toxicity and risks for adverse child outcomes including hyperkinetic disorders and autism, it remains widely used and continues to be endorsed by US physician groups and the US FDA. It is well-established that pregnancy intake of medications can have carcinogenic impacts on offspring, as shown by diethylstilbestrol (DES) and vaginal adenocarcinoma. Yet potential carcinogenic impacts from acetaminophen are understudied. This study will be conducted via linkage of national health insurance claims databases in Taiwan, including the Taiwan Maternal and Child Health Database (which includes the Pharmaceutical Register and the Birth Registry, among other sources) and the Cancer Registry. Data on demographic, gestational, and other factors will be available from other national registers. The Aims of this study are to investigate the role of acetaminophen in cancer risk, addressing needs voiced by regulatory agencies, for more thorough research to better understand the safety of acetaminophen in pregnancy and to inform regulatory recommendations.

项目概要大约 65% 的美国孕妇服用对乙酰氨基酚（在美国，品牌为泰诺；在欧洲，扑热息痛）。尽管人们越来越担心它在怀孕期间的安全性，但有报道称肝脏和发育毒性以及不良儿童结局的风险，包括多动症疾病和自闭症，它仍然被广泛使用，并继续得到美国医生的认可团体和美国 FDA。众所周知，怀孕期间服用药物可能会产生对后代的致癌影响，如己烯雌酚 (DES) 和阴道腺癌。然而，对乙酰氨基酚的潜在致癌影响尚未得到充分研究。这项研究将通过连接国家健康保险索赔数据库来进行台湾，包括台湾母婴健康数据库（其中包括药品登记处和出生登记处等）以及癌症登记处。有关人口、妊娠和其他因素的数据可从其他国家获得寄存器。这项研究的目的是调查对乙酰氨基酚在癌症风险中的作用，满足监管机构提出的需求，进行更深入的研究，以更好地了解对乙酰氨基酚在怀孕期间的安全性并告知监管机构建议。