More on SSRI’s and congenital malformations...

A new study is available that examined nearly a half million children born in Denmark (oh, the beauty of having readily available data!) between 1996 and 2003 finds a higher risk of septal heart defects (OR 1.99, 95% CI: 1.13 to 3.53) in those filling prescriptions for SSRI’s overall. Here is a link to the study:
http://www.bmj.com/cgi/reprint/339/sep23_1/b3569 Pedersen, L.H., et al. (2009). Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study. BMJ, 339(231).

This looks like a study that was carefully carried out, and it does provide further data that there are risks to the child from the mother’s treatment with an antidepressant drug early in pregnancy. I have mentioned in prior posts my concerns about use of psychotropic drugs during pregnancy (here is the link to my prior blog posting:
http://blogs.yale.edu/roller/page/mentalnotes?entry=psychotropic_drugs_during_pregnancy) The prior studies seem to show that there was greater risk of problems with using fluoxetine and paroxetine (which led to warnings issued). Particularly at risk were women using SSRI’s in early pregnancy, who also smoke. This of course is quite applicable to most of the women we treat in mental health settings. It is a good reminder to discuss the risk with women as well as discuss and plan appropriately if the woman is planning a pregnancy.

This study found greater risk of septal defects with use of sertraline (3.25 times the risk) and citalopram (2.52 times the risk). Added info offered with this study is that risk of heart defects were even greater in those using more than one type of SSRI (overall risk of heart malformations OR: 3.42, 95% CI: 1.4-8.3; and risk of septal defects OR: 4.7, 95% CI: 1.7-12.7). That also suggests that in younger women we carefully examine our polypharmacy practices (yes, I have a prior post on that as well… http://blogs.yale.edu/roller/page/mentalnotes/20081208) and won't get into that now.

This study is a good example of how difficult it really is to know harmful effects of treatments. There is a need for large population based studies to answer questions like this. The authors of this study (which evaluated a half million liveborn children from 1996 to 2003) suggest that studies be carried out in larger populations to determine the true risk (as # of exposed children was n=1370 of the half million studied). (i.e. if untoward events occur at a very low rate(say < 1 in 10,000), then the n exposed (n=1370) may not be large enough to expect to get even one occurrence)

I don't think we can afford to take lightly the risk of medications during pregnancy. A careful and well thought out plan for how to protect both Mother and baby is important.

I wonder if the prevalence of antidepressant use in pregnant women is higher in the US?