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Comments on “Reproductive toxicology studies supporting the safety of molindone, a dopamine receptor antagonist” (Gopalakrishnan et al., Birth Defects Research. 2018; 110(16):1250–1262)

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This article reports on a standard set of developmental and reproductive toxicity studies with molindone. I submit that the presented data does not support the major conclusion as stated in… Click to show full abstract

This article reports on a standard set of developmental and reproductive toxicity studies with molindone. I submit that the presented data does not support the major conclusion as stated in the Abstract (“Molindone was not developmentally toxic in rats or rabbits at 69X and 6X clinical exposures, confirming the reproductive safety of molindone”). Indeed, the rat range-finding and definitive EFD toxicity studies showed no indications of developmental toxicity based on presented data. However, in the prenatal/postnatal rat study the following were clear signals of developmental toxicity.

Keywords: birth defects; molindone; safety molindone; toxicity; defects research; toxicology

Journal Title: Birth Defects Research
Year Published: 2019

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