FDA Rules for Pregnancy and Lactation Labeling and Their Clinical Implications

Osborne, Lauren M.; Leistikow, Nicole; Rocha, Renan

doi:10.1007/978-3-030-29081-8_26

Cited by 1 publication

(1 citation statement)

References 39 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Presumably, the interest in this area has led to the incorporation of guidelines for preclinical developmental toxicity testing for pharmaceutical agents. Hence, the Food & Drug Administration (FDA) has assigned various categories (A, B, C, D, X) to all drugs based on the level of risk the drug poses to the fetus (Osborne et al, 2020) The long-term neurobehavioral aspect of developmental toxicity is an area, which unfortunately could not catch the attraction of the policy makers in past. This is the reason why no such guidelines are available for said testing for pharmaceutical agents, a potential risk yet to be completely deciphered.…”

Section: Introductionmentioning

confidence: 99%

Untitled

2021

Pak. J. Pharm. Sci

View full text Add to dashboard Cite

The depression during and after pregnancy cause significant exposure of fluoxetine to the child at early life through mother. This exposure to the child, during the vulnerable window of development, can have a long lasting impact on overall mental wellbeing. Long term neurobehavioral aspect of developmental toxicity is neglected as the part of testing requirements in the process of drug developmental. In this context, the present study was designed to study the possible effect of pre-weaning fluoxetine exposure on the social behavior of rats upon adulthood followed by assessing hippocampal morphometry (hematoxylin-eosin and silver staining) and post-synaptic density protein 95 (PSD-95) expression (using qPCR). Our data showed that the fluoxetine exposure (10, 50 and 100mg/kg) caused predominant increase in the social behavior of rats; the effect more pronounced in female rats. The morphometric analysis revealed significant increase in cell population and count of dentate gyrus (DG) region of hippocampus along with enhanced dendritic arborization. Furthermore, the PSD-95 expression was found to be down regulated in the fluoxetine treated group as compared to control. In conclusion, the present study demonstrate that the early post-natal exposure to fluoxetine cause hypersociability upon attaining adulthood, which may be attributed to enhanced neuronal proliferation and decrease PSD-95 expression in the hippocampus.

show abstract

Section: Introductionmentioning

confidence: 99%

Untitled

2021

Pak. J. Pharm. Sci

View full text Add to dashboard Cite

show abstract

FDA Rules for Pregnancy and Lactation Labeling and Their Clinical Implications

Cited by 1 publication

References 39 publications

Untitled

Untitled

Contact Info

Product

Resources

About