Amiodarone intravenous (Cordarone I.V.) in pediatric patients (July 26, 2001)

Health Canada and Sabex Inc. are notifying health care professionals that amiodarone IV leaches out a potentially harmful plasticizer (DEHP) from intravenous tubing. Further, the medication contains a preservative (benzyl alcohol), which may be associated with fatal "gasping syndrome" in neonates.

The drug

Amiodarone is an antiarrhythmic drug used to treat a variety of cardiac dysrhythmias. Sabex and Health Canada have issued a letter indicating that Amiodarone Hydrochloride for Injection has been found to leach out plasticizers, such as DEHP [di-(2-ethylhexyl) phthalate] from intravenous tubing, including PVC tubing. DEHP is used generally to increase tubing flexibility. Leaching increases when amiodarone is infused at higher concentrations or flow rates than indicated in the product monograph/package insert. Evidence exists in animal models that DEHP may adversely affect immature male reproductive tract development, particularly if the exposure is in doses which could occur in the treatment of a critically ill infant. Currently the safety and efficacy of amiodarone IV in the pediatric population has not been established, and its use in pediatric patients is not recommended.

A potentially fatal "gasping syndrome" in neonates (less than 1 month of age) can occur after intravenous administration of solutions containing the preservative benzyl alcohol, which is contained in amiodarone IV. Signs and symptoms of the gasping syndrome include metabolic acidosis progressing to respiratory distress. For other adverse effects, consult the product monograph.

Amiodarone is marketed in Canada under the brand names Cordarone and Cordarone IV.

What to do

There are no approved recommendations for using amiodarone IV in children. Benefits and risks of using the product in this context must be weighed by the attending physician and discussed with the patient's decision-makers. Alternative methods of dosing and administration may be considered (such as those described by Perry et al. J Am Coll Cardil 1996; 27: 1246-1250), which might reduce exposure to plasticizers but not to benzyl alcohol. Such methods of administration have not been evaluated by Health Canada.

Copyright 2001 Canadian Medical Association or its licensors