Edarbyclor Pregnancy Warnings
This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus.
US FDA pregnancy category: Not assigned.
Risk Summary: Discontinue this drug as soon as possible if pregnancy is detected.
Comments: Adequate methods of contraception should be encouraged.
Animal studies have revealed evidence of toxicity. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters reduces fetal renal function and increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy.
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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