Traditionally, studies on medicine safety during pregnancy and around the time of conception focus on the mothers. There is a need to explore the safety of paternal drug exposure and its potential effects on pregnancies. A recent publication from the ConcePTION project in Pharmacoepidemiology and Drug Safety outlines the knowledge gaps.
“We know very little about the effects of paternal drug exposure and its effects on their children. There are some studies, on for example on drugs to treat rheumatic disorders, depression, diabetes, seizures and epilepsy. But we found only 17 studies that met the inclusion criteria for our systematic review,” says Sandra Lopez-Leon, pharmacoepidemiologist at Novartis Pharma and Adjunct Faculty at PETS Rutgers University, and one of the authors.
The data that does exist about how fathers using medicines affect their unborn children is primarily from Nordic patient databases and North American databases that include insurance claims, electronic health records, and other administrative data. And most of the studies performed are for anti-inflammatory and anti-cancer medications.
In their systematic review of studies, the authors explored paternal medication exposure and pregnancy and infant outcomes. Exploring some of the biggest research databases for studies performed from 2012 through April 2023 – the review shows that very few studies have been performed on the topic.
By Anna Holm Bodin
Gaitonde, S., Moride, Y., Suarez, E., & Lopez-Leon, S. Where are the data to assess the safety of paternal drug exposure? A systematic review of secondary databases: A contribution from IMI conception, Pharmacoepidemiology & Drug Safety, 2024:33;2(e5764), DOI: 10.1002/pds.5764