Desipramine Labeling Revised

Kate Traynor

BETHESDA, MD 03 December 2009—New safety information has been added to the labeling (PDF) for desipramine hydrochloride, FDA announced Wednesday.

According to a Dear Health Care Professional letter from Sanofi Aventis U.S., "extreme caution" is needed when desipramine, a tricyclic antidepressant, is used by patients with a family history of sudden death, abnormal heart rhythm, or cardiac conduction disturbances.

The labeling also warns that in some patients, seizures have preceded an abnormal heart rhythm and death.

New information about overdosage has also been added to the labeling, including a statement that death from overdosage is more common in patients taking desipramine than other tricyclic antidepressants.

The labeling describes early electrocardiogram changes that signal an overdosage and recommends the use of oral activated charcoal for the early management of overdosage. Propofol has replaced phenytoin as a second-line treatment for seizures related to an overdosage, and a statement describing plasma desipramine measurement as the optimal guide to dosage monitoring has been deleted.