Drug exposure during pregnancy may pose a risk for both mother and child. The safety profile of maternal drug exposure during pregnancy has been established for several drugs. The potential risks of paternal drug use on pregnancy and an infant’s health was considered less likely, so studies on this topic are lacking. Nevertheless a number of theoretical mechanisms were put forward that do suggest a potential risk. Both medical specialists and Teratology Information Services are regularly confronted with questions on this topic, for which information in medical literature is sparse. Through this project information will be provided to facilitate decisions for treatment of men who want to start a family.
Pharmacovigilance Centre Lareb and medical specialists from four departments of the Erasmus MC (rheumatology, gastroenterology, dermatology and nephrology) are part of the project team. Patients organizations will be involved in all phases of the project.
Data will be collected using the Lareb Intensive monitoring system and the pregnancy drug register pREGnant for which information will be collected using dedicated web-based questionnaires.
This project will give an overview on the uncertainties of patients and their health care providers, gives insight in the current daily practice in the Netherlands and will provide additional information about the risk and safety of paternal autoimmune drug use in relation with family planning and pregnancy outcome and possible influences on the infant’s health.