Methadone Alert Conference

The following websites present the approval history and regulatory actions taken involving methadone. Methadone is a long-acting synthetic, narcotic drug, first used in the 1960’s as maintenance treatment for opiate addiction. The websites detail the use/indication and existing complications with the product.

FDA Information:

Drug Details of Dolophine Hydrochloride (Methadone Hydrochloride) Approval History (label, approval letters, etc).

FDA reviewed reports of death and life-threatening side effects. The following information reflects FDA’s current analysis of data available to FDA concerning this drug and provides guidance to healthcare professionals and patients on prescribing and potential side effects.

Prescribing information for Healthcare Providers:

New Prescribing Information (Dolophine label) approved on 11/17/2006

Healthcare Professional Sheet [PDF] or [HTML]

Patient Information Dolophine Hydrochloride CII [PDF]

FDA ALERT [11/2006]:  Death, Narcotic Overdose, and Serious Cardiac Arrhythmias

Other information:

Questions and Answers on the Federal Register Notice on Drugs and Biological Products Deemed to have Risk Evaluation and Mitigation Strategies.

Public Health Advisory