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Dronedarone Pregnancy and Breastfeeding Warnings

Brand names: Multaq

Medically reviewed by Drugs.com. Last updated on Apr 16, 2024.

Dronedarone Pregnancy Warnings

AU, US: Use is contraindicated.
UK: Use is not recommended.

AU TGA pregnancy category: D
FDA pregnancy category: X

Comment:
-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.

There are no controlled data in human pregnancy. Animal studies have revealed increased rates of external, visceral and skeletal malformations (cranioschisis, cleft palate, incomplete evagination of pineal body, brachygnathia, partially fused carotid arteries, truncus arteriosus, abnormal lobation of the liver, partially duplicated inferior vena cava, brachydactyly, ectrodactylia, syndactylia, and anterior and/or posterior club feet).

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.

FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Dronedarone Breastfeeding Warnings

AU and US: Use is contraindicated.
UK: 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: Unknown
Excreted into animal milk: Yes

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2009) "Product Information. Multaq (dronedarone)." sanofi-aventis

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. EMEA. European Medicines Agency (2007) EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid
  3. (2009) "Product Information. Multaq (dronedarone)." sanofi-aventis

Further information

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

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