Zemplar Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: C
US FDA pregnancy category: C
Animal studies showed decreased fetal viability, and increased newborn mortality was seen at maternally toxic doses. The drug crossed the placental barrier in an animal model. No teratogenicity was seen, however other vitamin D preparations have led to teratogenesis. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
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