The Dutch Pregnancy Drug Register: Suitable to Study Paternal Drug Exposures?

Author:

van der Mijle Annerose E.1,Woestenberg Petra J.1ORCID,Kosse Leanne J.1,van Puijenbroek Eugène P.12

Affiliation:

1. Netherlands Pharmacovigilance Centre Lareb, 5237 MH Hertogenbosch, The Netherlands

2. Groningen Research Institute of Pharmacy, PharmacoTherapy—Epidemiology & Economics, University of Groningen, 9713 AV Groningen, The Netherlands

Abstract

Paternal medication use around the time of conception is common, but information about its effects on pregnancy outcome and the health of the child is generally limited. The aim of this study is to examine the feasibility of studying paternal exposure in the Dutch Pregnancy Drug Register by using immunosuppressants as a proof of concept. In 113 of 15,959 pregnancies, long-term paternal immunosuppressant use was reported 3 months before conception. In total, 134 immunosuppressants were used. Pregnancy outcome was known for 54 cases and was in accordance with previous findings. Two spontaneous abortions, two premature births, six small for gestational age babies, and two major congenital malformations were reported. Time to pregnancy (TTP) was known for 9548 pregnancies, including 89 with paternal immunosuppressant use. TTP analysis did not show a difference in pregnancies with paternal immunosuppressant use compared to the control group. Moreover, the number of fertility treatments in the paternal immunosuppressant group was similar to the control group. In our opinion, it is feasible to use the Dutch Pregnancy Drug Register to study the effects of paternal exposure on pregnancy outcome. However, to study the potential effects on fertility, more information is needed, particularly since the beginning of pregnancy attempts.

Funder

ZonMw

Publisher

MDPI AG

Subject

Health, Toxicology and Mutagenesis,Public Health, Environmental and Occupational Health

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