The risk of congenital abnormalities in children fathered by men treated with azathioprine or mercaptopurine before conception.
ABSTRACT Immunosuppressive therapy with azathioprine and mercaptopurine is commonly used in patients with various chronic diseases. The few existing data on the reproductive safety of these drugs after paternal use before conception are inconclusive.
To examine the risk of congenital abnormalities in children fathered by men exposed to azathioprine or mercaptopurine before conception.
This was a Danish population-based cohort study, based on data from the Prescription Database, the Medical Birth Registry and the Hospital Discharge Registry of North Jutland County, Denmark. Fifty-four exposed pregnancies, in which the father filed a prescription for azathioprine or mercaptopurine (between 1 January 1991 and 31 December 2001) before conception, were included. The controls comprised 57 195 pregnancies with no paternal azathioprine or mercaptopurine use.
Four children with congenital abnormalities (underlying paternal diseases: glomerulonephritis and severe skin disease) were found in 54 exposed pregnancies (7.4%), compared with 2334 (4.1%) in controls. The adjusted odds ratio for congenital abnormalities in children fathered by men treated with azathioprine or mercaptopurine was 1.8 (95% confidence interval, 0.7-5.0).
Our data may indicate that paternal use of azathioprine or mercaptopurine before conception is associated with an increased risk of congenital abnormalities. However, more data are needed to determine whether the association is causal.
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ABSTRACT: To identify and describe European health care databases that can be used for pediatric pharmacoepidemiological research. A web-based survey was conducted among all European databases that were listed on the website of the International Society of Pharmacoepidemiology (ISPE) and/or known by an expert group. The survey comprised of questions regarding (a) the nature of the database, (b) database size, (c) demographic, clinical and drug related data provided, (d) cost, and (e) accessibility of the database. A total of 25 data sources from 12 European countries were identified and invited to participate in the survey. Responses were obtained from 21 (84%) databases located in 10 different European countries. Seventeen databases were included in the assessment comprising a total of at least 9 million children aged 0-18 years. The majority of databases are based on outpatient data and all keep either prescription or drug dispensing data. Ten databases are based on electronic patient records from primary care physicians and five databases are predominantly claims oriented. Three databases do not belong to either of the above mentioned categories. Almost all of the databases can be used for pediatric drug utilization studies. For drug safety studies it is more appropriate to use electronic patient record databases because of the available clinical information and the potential to obtain additional information. There are many European healthcare databases providing an enormous potential for pediatric pharmacoepidemiological research. Future research should focus on methods to bring data from different databases together to use the full capacity effectively.Pharmacoepidemiology and Drug Safety 10/2008; 17(12):1155-67. · 2.53 Impact Factor