Amlodipine and valsartan Pregnancy Warnings
Use should be avoided; use is contraindicated per some authorities.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Comments: Adequate methods of contraception should be encouraged.
Animal studies with this drug have revealed evidence of fetotoxicity in association with maternal toxicity. Animal studies with amlodipine have revealed evidence of prolonged gestation, increased stillbirths, and decreased postnatal survival. Animal studies with valsartan have revealed evidence of fetal loss, decreased fetal weight, decreased birth weight, decreased postnatal growth and survival, a slight delay in physical development of offspring, decreased RBC parameters, and altered renal hemodynamics. 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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