Osmoprep Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: Exempt
US FDA pregnancy category: C
Comments:
-It is unknown if this drug can cause fetal harm when given to a pregnant woman.
Animal studies have not been conducted. There are no controlled data in human pregnancy.
AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.
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
