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June 17, 1998

Risk of Fetal Anomalies With Exposure to Selective Serotonin Reuptake Inhibitors

Author Affiliations

Margaret A.WinkerMD, Senior EditorIndividualAuthorPhil B.FontanarosaMD, Senior EditorIndividualAuthor

JAMA. 1998;279(23):1873. doi:10-1001/pubs.JAMA-ISSN-0098-7484-279-23-jbk0617

To the Editor.— I congratulate Dr Kulin and colleagues1 for undertaking the daunting task of data collection from 9 teratology information centers. This is important information for practitioners who care for pregnant women with major depression. However, I have some concerns regarding the study design and conclusions.

Ascertainment of SSRI exposure comes from self-reporting by women to teratology centers. Although this seems to be a reasonable approach, this may represent a skewed population with a lesser degree of depression (and potentially decreased drug exposure). Severely depressed, hospitalized patients may lack either the energy or the degree of cognitive functioning needed to voluntarily call a teratology hotline. However, I have greater concern with the choice of the control group. Pregnant women with concerns of teratogen exposure (even if deemed nonsignificant at a later date) do not represent a "low-risk" control population. Indeed, the high risk of "major" anomalies (3.8%) in this control group confirms that conclusion. A more appropriate control group would be random selection of women from a low-risk or routine prenatal clinic. Another interesting control group would be women with major depression who are treated with tricyclic antidepressants since the choice for women with major depression for the study groups should be those taking an SSRI or a tricyclic, not an SSRI or no medication.