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Dronedarone Pregnancy and Breastfeeding Warnings

Dronedarone is also known as: Multaq

Dronedarone Pregnancy Warnings

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). 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.

FDA pregnancy category: X Use of dronedarone is contraindicated. Women of childbearing potential should be encouraged to use adequate contraception.

Dronedarone Breastfeeding Warnings

Dronedarone is contraindicated in nursing mothers. A decision should be made to discontinue nursing 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 The effects in the nursing infant are unknown. Maternal dronedarone administration was associated with minor reduced body weight gain in the offspring of rats during a pre- and postnatal study.

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