FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction

Abstract

The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

Effect of Venlafaxine, Pramipexole, and Valsartan on Spermatogenesis in Male Rats

“…FDA approved some drugs, which impairs human spermatogenesis including pramipexole, but no data has been found on animals and humans. 16 …”

Effects of a new thyrotropic drug isolated from Potentilla alba on the male reproductive system of rats and offspring development

“…Specifically, should PADE be prescribed to male patients with thyroid dysfunction? The reliability of studies investigating spermatotoxicity in animals was investigated by Elizabeth Rayburn and colleagues [ 32 ]. They examined 235 FDA-approved small molecule drugs with spermatotoxic effects, and only 49 had documented negative impact on men’s reproductive health.…”

Eletroestimulação De Alta Voltagem No Reparo Tecidual De Lesão Por Pressão: Um Relato De Experiência

“…A partir disto, estes estudos podem eliminar candidatos não promissores ou ajudar a melhora-los a partir de modificações estruturais, facilitando e otimizando do processo pelo uso destas estratégias (MODA, 2011;RAYBURN et al, 2017 Após este intervalo de tempo o aquecimento foi interrompido e o término da reação foi verificado por (CCD). Em seguida, a solução contida no balão foi filtrada e o solvente foi removido sob pressão reduzida utilizando evaporador rotativo.…”