Critical Review: Prenatal Fluoxetine Exposure, Neonatal Toxicity, and Developmental Outcomes

Raymond Lattanzio

Advisor: .

Enterprise Hall, 418
April 24, 2008, 08:00 PM to 07:00 PM

Abstract:

In 1988, Ely Lilly and Company introduced fluoxetine (better known by its brand name, Prozac) for the treatment of depression, which occurs most frequently in women during their reproductive years. Women undergoing pharmacotherapy for depression may become pregnant during treatment inadvertently exposing their unborn to the drug or may experience depression so severely as to necessitate treatment even when pregnancy is known. However, the consequences of prenatal fluoxetine exposure to the developing fetal nervous system are not completely understood. A few studies examine the possibility of negative birth outcomes and alterations in early post-natal learning following prenatal fluoxetine exposure, but results are inconclusive and often contradictory of one another. This pattern holds for the larger corpus examining fluoxetine exposures at different points in the life span to brain-alterations and learning behavior. This dissertation critically reviews the fluoxetine-related corpus, with particular attention focused on studies of neonatal toxicity and behavioral alterations following prenatal exposures in humans. Significant differences were found in patterns of results reporting in the fluoxetine-related literature based on the presence or absence of corporate support from fluoxetines manufacturer. In studies where no corporate support was acknowledged, findings tended to be less favorable regarding the consequences of fluoxetine than in those studies for which corporate support was recognized. A trend in the differences of reporting patterns was recognized in studies related to prenatal fluoxetine exposure, neonatal toxicity, and behavioral teratogenicity which resembles that described for the larger corpus. Methodological differences were observed which seem related to patterns of corporate support for prenatal fluoxetine research and could account for some of the disparate results, including (but not limited to): lack of proper control groups and the use of poly-drug studies that failed to control for the influence of other drug exposures on outcome variables. Two new studies are proposed which address the methodological concerns articulated in this dissertation for the purpose of advancing scientific understanding of prenatal fluoxetine exposure and fetal safety, while clarifying outstanding issues in the current corpus. Implications for undergraduate education in the conduct and interpretation of multi-disciplinary research are discussed.