Zolinza Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on its mechanism of action and findings from animal studies, this drug can cause fetal harm when administered to a pregnant woman. Administration in animal studies during organogenesis caused adverse developmental outcomes at maternal exposures approximately 0.5 times the equivalent human exposure.
Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Animal studies have revealed evidence of decreased fetal weights, incomplete ossifications of the skull, thoracic vertebra, sternebra, and skeletal variations (e.g., cervical ribs, supernumerary ribs, vertebral count, sacral arch variations) at the highest dose tested. Reductions in mean live fetal weight, an elevated incidence of incomplete ossification of the metacarpals, and malformations of the gall bladder were also reported. There are no controlled data in human pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.
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