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U.S. Department of Health and Human Services


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Dolophine (methadone hydrochloride)

Audience: Pain management specialists, pharmacists, and other healthcare professionals
Indication: Treatment of moderate to severe pain not responsive to non-narcotic analgesics; detoxification of opioid addiction; and maintenance treatment of opioid addiction
[Posted 11/27/2006] 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.

[November 27, 2006 - Public Health Advisory - FDA]
[November 27, 2006 - Healthcare Professional Sheet - FDA]
[November 27, 2006 - Prescribing Information - Roxane]