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Amlodipine / valsartan Pregnancy and Breastfeeding Warnings

Amlodipine / valsartan is also known as: Exforge

Medically reviewed on Jul 18, 2017

Amlodipine / valsartan Pregnancy Warnings

AU: Use is contraindicated.
UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters.
US: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: D

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. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Amlodipine / valsartan Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes (amlodipine); Unknown (valsartan)
Excreted into animal milk: Yes (valsartan)

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Exforge (amlodipine-valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Exforge (amlodipine-valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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