In ordinary pharmaceutical trials, you can administer medication to one group of volunteer subjects while giving a placebo to the other group and compare the responses to identify statistically significant effects, both positive and negative. However, medical ethics excludes this type of drug testing on pregnant women and their babies, creating a need for different research methodologies that are less likely to indicate clear cause-and-effect. As such, many psychotropic drugs are not confidently recommended to pregnant women, not necessarily because there is evidence of harm, but because there is no evidence of lack of harm. This can be a very frustrating and stressful state of affairs for pregnant women living with depression–how do you make medical decisions without absolutely clear-cut evidence?
As more women have chosen to take antidepressants during pregnancy, particularly SSRIs, a larger pool of data has been developed that may help you with your own decision regarding treatment. A study published in the British Medical Journal last month examined data on over 38,000 women in the United States who gave birth between 1997 and 2009. The researchers looked at the relationship between birth defects and antidepressant use during the month of conception or in the first trimester of pregnancy. No heightened risk of birth defects was observed in babies whose mothers had taken Zoloft, Celexa, or Lexapro. Although no causal link has been established, the study did find that Prozac and Paxil produce a 2-3.5 times increased relative risk of birth defects, including heart, abdominal wall, skull, and brain defects. In absolute terms, the differences observed were very small; Paxil increased the risk of brain and skull defects from 2 to 7 per 10,000 births and the risk of heart defects from 10 to 24 per 10,000 births. Similarly, a 2010 study found that Wellbutrin was also associated with a higher rate of congenital heart defects, but that the absolute risk remained low.
Less reassuring is the research regarding the neurodevelopmental effects of fetal antidepressant exposure. In a controversial article published last year in the New York Times, Roni Caryn Rabin cited studies that link SSRI use to lower language competence, premature birth, increased risk of ADHD, and lower Apgar scores. Critics of the piece, including prominent health care professionals, accused Ms. Rabin of alarmism, cherry picking, and trivializing the impact of depression on women’s lives. Dr. Elizabeth Fitelson, a psychiatrist specializing in mental health treatment for pregnant women, told The New Yorker:
SSRI exposure does have neurodevelopmental effects on some (but certainly not all) babies exposed in utero, but the jury is basically still out about what, if any, long-term neurodevelopmental effects there are. We don’t know whether the relatively subtle neurodevelopmental effects observed in exposed babies continue to be significant later on in childhood, which babies are more likely to be affected in utero by either medication or maternal mood, and how to tease apart the effects of each.