FDA - MedWatch - Dolophine (Methadone Hydrochloride) - Reports of Death, Narcotic Overdose, and Serious Cardiac Arrhythmias

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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

>

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