SSRI use and pregnancy, birth defects
Prozac and Pregnancy
Mon/Jun/07 09:35 PM
This week's issue of the New England Journal of Medicine has 2 articles on the risks of birth defects in children born to women who take "Seletive Serotonin-Reuptake Inhibitors" (SSRI's). Since depression is common among women of childbearing years and may affect up to 10% of women who are pregnant, the issue of what constitutes safe treatment for mother and developing child is an important topic. SSRI's became available in the late 1980's and became the dominant medical intervention for depression by the 1990's. They promised less potential side effects, a possible faster onset of effective action and less potential for death by overdose. It became logical that women taking SSRI's might become pregnant and early studies suggested that SSRI's could produce omphalocele, craniosynostosis and heart defects. Obviously no one wants to keep a women on such a teratogen and drug companies want to play down effects that cannot be clearly linked to their products.
The first study by Louik et al has been ongoing since 1976. Five study centers (Boston, Philadelphia, Toronto, San Diego and portion of New York State are involved. Cases of birth defects are identified and then exposure is assessed using an interview within 6 months of delivery that questions mothers about demographics, reproductive and medical factors, cigarette smoking and the consumption of alcohol and caffeine. Medication (both prescription and over the counter), vitamin, mineral and herbal intake are also reviewed. Pregnancy history including questions about specific conditions occurring in pregnancy and the medications used for those conditions is reviewed. These cases were then matched with controls with similar demographics.
The current paper from this study looked at women whose last menstruation was between 1/1/93 and 12/31/04. Cases of defects excluded those who had know inherited disorders, syndromes, defects with known causes and metabolic disorders (like PKU). About 23% of the case mothers did not participate as did about 25% of the control mothers. An additional 15% of case mothers and controls did not respond or were unavailable to interview.
The researches looked specifically at exposure in the first trimester which they defined as use of any SSRI from 28 days before the last menstrual period through the fourth lunar month (112 days after the last menstrual period.) Of note the researchers excluded 79 women who took MORE THAN ONE SSRI during this period. A total of 9849 infants with malformations and 5860 control infants were included in their statistical analysis.
Although overall use of SSRI's by their analysis was not shown to increase the overall risk of the birth defects described above, the authors do point to an associated risk of the use of sertraline and omphalocele and septal defects as well as an increased association between paroxetine and right ventricular outflow tract obstruction. Of note was the fact that overall risk of defects was quite small.
The second study by Alwan et al used a more exhaustive list of defects and data. They also found little association with the defects mentioned in the first study but noted a potential association between SSRI use and the occurrence of anencephaly , crainiosynostosis and omphalocele. This study outlines some of the theories as to why an association with these conditions may exist.
Bottom line? As with most conditions during pregnancy you must carefully weigh the risks of treatment vs non-treatment. Depression with potential for suicide, poor nutrition, abuse by spouse and other likely unknown effects on the mother and fetus must be weighed against the drug risks. In this case we know the risk, as it appears to exist, is relatively small. Careful use of medications and use of those least linked to these defects is the most prudent course of action.
The first study by Louik et al has been ongoing since 1976. Five study centers (Boston, Philadelphia, Toronto, San Diego and portion of New York State are involved. Cases of birth defects are identified and then exposure is assessed using an interview within 6 months of delivery that questions mothers about demographics, reproductive and medical factors, cigarette smoking and the consumption of alcohol and caffeine. Medication (both prescription and over the counter), vitamin, mineral and herbal intake are also reviewed. Pregnancy history including questions about specific conditions occurring in pregnancy and the medications used for those conditions is reviewed. These cases were then matched with controls with similar demographics.
The current paper from this study looked at women whose last menstruation was between 1/1/93 and 12/31/04. Cases of defects excluded those who had know inherited disorders, syndromes, defects with known causes and metabolic disorders (like PKU). About 23% of the case mothers did not participate as did about 25% of the control mothers. An additional 15% of case mothers and controls did not respond or were unavailable to interview.
The researches looked specifically at exposure in the first trimester which they defined as use of any SSRI from 28 days before the last menstrual period through the fourth lunar month (112 days after the last menstrual period.) Of note the researchers excluded 79 women who took MORE THAN ONE SSRI during this period. A total of 9849 infants with malformations and 5860 control infants were included in their statistical analysis.
Although overall use of SSRI's by their analysis was not shown to increase the overall risk of the birth defects described above, the authors do point to an associated risk of the use of sertraline and omphalocele and septal defects as well as an increased association between paroxetine and right ventricular outflow tract obstruction. Of note was the fact that overall risk of defects was quite small.
The second study by Alwan et al used a more exhaustive list of defects and data. They also found little association with the defects mentioned in the first study but noted a potential association between SSRI use and the occurrence of anencephaly , crainiosynostosis and omphalocele. This study outlines some of the theories as to why an association with these conditions may exist.
Bottom line? As with most conditions during pregnancy you must carefully weigh the risks of treatment vs non-treatment. Depression with potential for suicide, poor nutrition, abuse by spouse and other likely unknown effects on the mother and fetus must be weighed against the drug risks. In this case we know the risk, as it appears to exist, is relatively small. Careful use of medications and use of those least linked to these defects is the most prudent course of action.
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