Comments: Based on animal data, this drug may cause fetal harm.
Animal studies have revealed evidence of adverse developmental effects (increased mortality, decreased growth, delayed sexual development, altered behavior) at clinically relevant doses; most of these effects occurred at doses that were also associated with maternal toxicity. Although IV administration of this drug (3, 20, or 200 mg/kg) prior to and throughout mating in male and female animals and continuing in females to gestation day 7 had no effect on fertility, disruption of the estrus cycle and mating behavior were observed at the highest dose tested. No effects on reproductive function were observed at the lower doses, which are up to 3 times the recommended human dose on a body surface area basis. There are no controlled data in human pregnancy.
In animals administered this drug from gestation day 17 throughout lactation, adverse effects were observed including maternal toxicity, increased stillbirths, and delayed physical development (vaginal opening) and mortality in offspring.
Safety has not been established; benefit should outweigh risk.
"Product Information. Radicava (edaravone)." MT Pharma America, Jersey City, NJ.