Preclinical risk assessment of drug-induced hypo- and hyperprolactinemia.

Drug-induced changes in prolactin signaling may obscure interpretation of preclinical toxicological endpoints. However, with informed consideration, classic hallmarks of hypo-/hyperprolactinemia can be recognized in short- and long-term rodent bioassays. Findings can be supported and expanded with additional in vivo and in vitro datasets. When taken together with human epidemiological evidence pertaining to the consequences of drug-induced hypo-/hyperprolactinemia, such findings permit both an analysis of human relevance and an assessment of human risk.