No it is not. At the time there was no regulatory requirement to test in pregnancy. The only reason it never effected the USA is the FDA were (and are) so slow

No it is not. At the time there was no regulatory requirement to test in pregnancy. The only reason it never effected the USA is the FDA were (and are) so slow that the problem was found out before they got around to approving it. If the drug company had launched in the USA first the FDA would have allowed it to be sold. Interestingly it was tested in pregnant mice, but in mice it doesn't have the same effect as in humans.