May 22 2022

Classification of the active ingredient amiodarone

Risk level in pregnancy: This medicine is classified as Category D.

There are no adequate studies on the use of this medicine in pregnant women. Amiodarone crosses the placenta and can cause fetal harm when administered to a pregnant woman. Because this medication is removed slowly, the drug must be discontinued several months before a woman can become pregnant to prevent the drug influence on the embryo or fetus. Ifr a woman become pregnant while taking amiodarone, should be warned of the risks for the fetus to continue using the drug.

The use of amiodarone in pregnancy is justified only if the potential benefit clearly outweighs the risk to the fetus.

In laboratory animals, this substance is toxic to the mothers and fetuses, especially from 10 mg/kg/day, increasing fetal resorption with growth retardation and ossification, but not malformations.

The use of this medicine during pregnancy is rare, although there have been more than twenty observations and some reports of congenital goiter, hyper and hypothyroidism, because the drug has 75 mg of iodine per 200 mg of amiodarone.

In humans, have been reported major side effects related to the administration of amiodarone, either after birth and/or during the neonatal period, as bradycardia, QT prolongation, increase or decrease in T4, with or without variation of TSH, low weight for gestational age and intrauterine growth retardation, elevated serum iodine, delayed psychomotor development, language disorders, goiter, hypothyroidism and congenital cardiac septal defects. Not conclusively established the relationship between some of these effects and the use of amiodarone by the mother.

Other alterations were detected in the follow-up of a cohort of patients receiving amiodarone along with other substances, such as antiarrhythmics, digitalis and beta-blockers. A newborn presented hypotonia, hypertelorism and micrognathia associated with psychomotor retardation.

Update 18.07.2009

Meaning of 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.