Keveyis Pregnancy Warnings
This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
US FDA pregnancy category: C
Teratogenic effects (fetal limb reduction defects) were reported following oral administration of this drug in pregnant animals during organogenesis at 350 mg/kg, or 17 times the maximum recommended human dose (200 mg/day) on a body surface area (mg/m2) basis. A no-effect dose has not been established. There are no adequate and well-controlled studies in pregnant women.
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.
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