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
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