Ophthalmic Drugs Advisory Committee July 12, 2004
risk from Tazarotenic acid in
ng drug in semen which is about 1/ 5,000th of a single 4.5 mg capsule
is about 1/6,000 of the highest oral dose that was
not teratogenic in animals.
human may be more sensitive than animals. So instead of 1/6000 this may be only 1/600 to 1/16 human teratogenic dose based on data from other retinoids. Plus, the vaginal route may produce greater exposure to the fetus than the oral route. So this safety margin may be reduced even more.