French drugmaker Sanofi-Aventis SA has warned that its antidepressant Norpramin should be given with extreme caution to patients with a history of certain heart problems, the U.S. Food and Drug Administration said on Wednesday.
The label for Norpramin (desipramine hydrochloride tablets USP) will also warn that seizures precede abnormal heart rhythms and death in some patients. The heart conditions include a family history of sudden death, abnormal heart rhythms, and heart conduction disturbances.
The company’s letter to FDA and health professionals also said an overdose of Norpramin has shown a higher death rate than overdoses of other tricyclic antidepressants.