Magazine article Clinical Psychiatry News

FDA Issues Advisory on Methadone

Magazine article Clinical Psychiatry News

FDA Issues Advisory on Methadone

Article excerpt

Reports of deaths, cardiac arrhythmias, respiratory depression, and other serious adverse events in people treated with methadone for pain prompted the Food and Drug Administration to issue a public health advisory and revise its prescribing information for methadone hydrochloride.

The advisory, which appeared on the FDA's Web site, states that deaths and life-threatening side effects have been reported in patients just starting treatment with methadone and in those who have switched from other narcotic analgesics to 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)," according to the information for health care professionals also posted on the site. The FDA emphasizes that physicians who prescribe methadone should be familiar with the drug's toxicities and distinctive pharmacologic properties, and that patients on methadone should be closely monitored, particularly when treatment is started and when the dose is adjusted.

The FDA has not changed any requirements governing methadone administration or dosage, according to officials who participated in a teleconference about the advisory. The new label represents the first revision in decades, however, and contains prescribing information not previously available.

For example, an expanded section on drug-drug interactions includes drugs that did not exist when physicians started prescribing methadone for pain control in the 1940s. The revision also contains a new table on converting oral morphine to oral methadone for chronic administration.

Conversion tables for other opioids and time frames for methadone rotation are not provided--primarily because these are difficult issues. "Where we did not see consensus in the literature we remained silent," said Dr. …

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