Lotronex Pregnancy Warnings
Animal models have failed to reveal evidence of impaired fertility and fetal harm at doses up to 40 mg/kg/day. There are no adequate and well-controlled studies in pregnancy.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: B
See references
