Elestat Pregnancy Warnings
Benefit should outweigh risk.
US FDA pregnancy category: C
A study in rats using maternally toxic oral doses (150,000 times the recommended ocular human dose) has not revealed embryofetal effects. However, at 90,000 the recommended ocular human, reduced pup weight was observed. Resorptions and abortions have been reported in rabbits with oral doses at 55,000 times the recommended ocular human dose.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references