Irbesartan Pregnancy Warnings
Use is not recommended during pregnancy, and some authorities consider it contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned
Risk Summary: This drug can cause fetal harm when administered to a pregnant woman.
Comments: If a pregnancy is detected, this drug should be discontinued as soon as possible. Adequate methods of contraception should be encouraged.
Animal studies have revealed evidence of maternal mortality and abortion in addition to increased early resorptions and fetal toxicity. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity (reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension), and death. 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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