Prenatal exposure to paracetamol and the risk of urogenital system disorders or neurodevelopmental disorders in offspring: a systematic review of observational studies

Study identification

• EU PAS number:
  EUPAS33976
• Study ID:
  33977
• Official title and acronym:
  Prenatal exposure to paracetamol and the risk of urogenital system disorders or neurodevelopmental disorders in offspring: a systematic review of observational studies
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  Evaluating the safety of medicines exposure during pregnancy involves several challenges, including confounding by indication, i.e. the event for which the medicine being prescribed may be directly associated with the outcome, and confounding by severity, i.e. women with more severe symptoms may be more likely to be exposed to the medicine, often at higher doses and for longer periods of time. The aim of this systematic review is to provide an overview of the available observational studies looking at the association between maternal paracetamol exposure during pregnancy and the risk of neurodevelopment disorders and urogenital system disorders in offspring. The review focuses on the methodology used in these observational studies and whether additional comparisons and reference groups have been used to evaluate the associations and the type of confounders that have been included in existing analyses. This approach follows that used in a recent publication assessing studies measuring the association between antidepressant exposure during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder in offspring. The use of different comparator or reference groups in this publication provided supportive evidence examining whether statistically significant associations observed comparing risk in exposed women to risk in all unexposed women subject to confounding by indication was more or less likely to be causal 1.This review aims to provide some insight to whether the existing studies provide sufficient information to help determine whether the associations between maternal paracetamol exposure during pregnancy and the risk of neurodevelopment disorders and urogenital system disorders in offspring are likely to be causal, and to help make recommendations for or how to potentially address these challenges in further studies.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned:01/03/2018

Actual:01/03/2018

Study start date

Planned:02/04/2018

Actual:02/04/2018

Data analysis start date

Planned:03/04/2018

Actual:03/04/2018

Date of final study report

Planned:04/06/2018

Actual:04/06/2018

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable