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U.S. Department of Health and Human Services

Safety

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Cordarone I.V. (amiodarone HCl)

Audience: Neonatologists, Pediatricians, Cardiologists, and other healthcare professionals

Wyeth-Ayerst Pharmaceuticals notified health care professionals of two safety-related changes to the Cordarone IV (amiodarone HCl) prescribing information, describing potentially fatal or developmental side effects associated with use of this product in neonatal and infant pediatric patients. Wyeth-Ayerst Pharmaceuticals is aware that Cordarone IV is used off-label to treat arrhythmias in pediatric patients. The safety and efficacy of amiodarone IV in the pediatric population have not been established; therefore, its use in pediatric patients is not recommended.

[June 08, 2001 - Letter - Wyeth-Ayerst Pharmaceuticals]