Maternal acetaminophen use and childhood cancer

项目摘要 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）。尽管越来越多的人担心它在怀孕期间的安全性， 肝脏和发育毒性以及儿童不良结局的风险，包括多动性 尽管它被广泛使用，并继续得到美国医生的认可， 集团和美国FDA。众所周知，怀孕期间服用药物会导致 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。 这项研究将通过链接国家健康保险索赔数据库进行， 台湾，包括台湾母婴健康数据库（其中包括 药物登记处和出生登记处，以及其他来源）和癌症登记处。 人口统计学、妊娠和其他因素的数据将从其他国家/地区获得。 注册。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， 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.

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.