Neurodevelopment is a complex set of functional domains. To assess whether or not brain development is affected by exposure to medicines during pregnancy, different aspects of functioning need to be investigated. This includes including cognitive, motor, behavioural and emotional skills as well as any clinical disorders such as autistic spectrum disorder or ADHD. ConcePTION researchers gathered 25 experts from 13 countries with diverse professional backgrounds to develop recommendations on how to conduct studies on pregnancy, medicine safety and neurodevelopment.
ConcePTION is building an ecosystem to support research on the safety of medicines during pregnancy and breastfeeding. Part of this mission includes developing methods for this research, to make sure the results are useful to the companies that develop medicines, the authorities that approve them and in the end to the health care professionals that prescribe them. Today, there is a large knowledge gap. In a recent publication, ConcePTION researchers have explored expert opinion with a special focus on foetal brain development and later child neurodevelopmental outcomes.
As in any research field, different methodological approaches also have different strengths and weaknesses. A triangulation of evidence from different sources is required to able to draw conclusions. However, there is a lack of evidence, not only in pregnancy pharmacovigilance in general, but also in relation to foetal brain development particularly.
Although brain development is complex and any large deviations in development may be detected already in infancy, the recommendations highlight the importance of more long-term follow up. The human brain is not fully developed until the age of 25-30, which according to the recommendations means there is reason to follow up brain development in children also in adolescence when the brain has matured more.
“Only twenty-five percent of studies on medicine safety in pregnancy take neurodevelopment into account. It is an area where improvements are needed. Our recommendations include a set of criteria to prioritise which medications that should automatically require investigation into this as part of the medicine safety monitoring,” says Rebecca Bromley, [Senior Research Fellow based at The University of Manchester and Royal Manchester Children’s Hospital] and part of the ConcePTION work stream on neurodevelopmental outcomes.
Bromley R. L., Bickle Graz M., Bluett-Duncan M., Chambers C., Damkier P., Dietrich K., Dolk H., Grant K., Mattson S., Meador K. J., Nordeng H., Oberlander T. F., Ornoy A., Revet A., Richardson J., Rovet J., Schuler-Faccini L., Smearman E., Simms V., Vorhees C., Wide K., Wood A., Yates L., Ystrom E., Supraja T. A., Adams J. (2023) Expert consensus on neurodevelopmental outcomes in pregnancy pharmacovigilance studies. Frontiers in Pharmacology (14)2023. DOI: 10.3389/fphar.2023.1094698
By Anna Holm Bodin