Adverse Effects
No long-term studies to evaluate the carcinogenic potential of mifepristone have been performed. Results from studies conducted in vitro and in animals have revealed no genotoxic potential for mifepristone.
Neonatal exposure to a single large dose of mifepristone in rats was not associated with any reproductive problems, although chronic low-dose exposure of newborn rats to mifepristone was associated with structural and functional reproductive abnormalities.
Teratology studies in mice, rats and rabbits revealed teratogenicity for rabbits, but not rats or mice. The rate of birth defects in human infants exposed in utero to mifepristone and misoprostol is very low, and may be due to misoprostol alone.
A postmarketing summary found that, of about 1.52 million women who had received mifepristone until April 2011 in the US, fourteen were reported to have died after application. Eight of these cases were associated with sepsis; the other six had various causes like drug abuse and suspected murder. Other incidents reported to the FDA included 612 non-lethal hospitalizations, 339 blood transfusions, 48 severe infections, and 2,207 (0.15%) adverse events altogether.
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