Presented at the 28th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, 23–26 August 2012, Barcelona, Spain.
Article first published online: 26 APR 2013
Copyright © 2013 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 22, Issue 7, pages 783–793, July 2013
How to Cite
Lind, J. N., Tinker, S. C., Broussard, C. S., Reefhuis, J., Carmichael, S. L., Honein, M. A., Olney, R. S., Parker, S. E., Werler, M. M. and for the National Birth Defects Prevention Study (2013), Maternal medication and herbal use and risk for hypospadias: data from the National Birth Defects Prevention Study, 1997–2007. Pharmacoepidem. Drug Safe., 22: 783–793. doi: 10.1002/pds.3448
This article was published online on April 26, 2013. Errors were subsequently identified. This notice is included in the online and print versions to indicate that both have been corrected [July 3, 2013]
- Issue published online: 3 JUL 2013
- Article first published online: 26 APR 2013
- Manuscript Accepted: 13 MAR 2013
- Manuscript Revised: 4 MAR 2013
- Manuscript Received: 17 DEC 2012
- birth defects;
- drug safety;
To investigate associations between maternal use of common medications and herbals during early pregnancy and risk for hypospadias in male infants.
We used data from the National Birth Defects Prevention Study, a multi-site, population-based, case–control study. We analyzed data from 1537 infants with second-degree or third-degree isolated hypospadias and 4314 live-born male control infants without major birth defects, with estimated dates of delivery from 1997 to 2007. Exposure was reported use of prescription or over-the-counter medications or herbal products, from 1 month before to 4 months after conception. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were estimated using multivariable logistic regression, adjusting for maternal age, race/ethnicity, education, pre-pregnancy body mass index, previous live births, maternal subfertility, study site, and year.
We assessed 64 medication and 24 herbal components. Maternal uses of most components were not associated with an increased risk of hypospadias. A new associations was observed for venlafaxine (aOR 2.4; 95%CI 1.0, 6.0) [Correction made here after initial online publication.]. The previously reported association for clomiphene citrate was confirmed (aOR 1.9; 95%CI 1.2, 3.0). Numbers were relatively small for exposure to other specific patterns of fertility agents, but elevated aORs were observed for the most common of them.
Overall, findings were reassuring that hypospadias is not associated with most medication components examined in this analysis. New associations will need to be confirmed in other studies. Increased risks for hypospadias associated with various fertility agents raise the possibility of confounding by underlying subfertility. Copyright © 2013 John Wiley & Sons, Ltd.