November 27, 2006

FDA ALERT

Subject: FDA - MedWatch - Dolophine (Methadone Hydrochloride) - Reports of Death, Narcotic Overdose, and Serious Cardiac Arrhythmias
 
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
 
FDA notified healthcare professionals of reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone.  These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone's cardiac toxicities (QT prolongation and Torsades de Pointes).
 
The reports underscore the importance of knowing methadone's toxicities and unique pharmacologic properties, including dosing and monitoring recommendations.
 
Read the complete MedWatch 2006 Safety summary, including links to the FDA Healthcare Professional Sheet, Patient Information Sheet, and new prescribing information for Dolophine regarding this issue at:
 
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Methadone