Herbal Spotlight
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NEW WARNING
Sanofi-Aventis U.S. issued a "Dear Health Care Professional" letter about revisions made to prescribing information for desipramine hydrochloride (Norpramin), a tricyclic antidepressant. The revisions include adding patients with a family history of sudden death, cardiac arrhythmias, or cardiac conduction defects to the "Warnings" section, along with the statement that seizures may appear before cardiac arrhythmias and death in some patients. Additionally, major revisions were made to the "Overdosage" section, including a statement that overdosage with desipramine has resulted in a higher death rate than overdoses with other tricyclic antidepressants.
The new prescribing information also warns of early ECG changes, such as widening of the QRS complex, and recommends administering I.V. sodium bicarbonate and providing hyperventilation for patients experiencing these signs to prevent arrhythmias. When arrhythmia occurs despite alkalinization, overdrive pacing or beta-agonist or magnesium infusion may be necessary. It also recommends administering activated charcoal to those individuals who present early after overdose.
To report any adverse events related to desipramine hydrochloride administration, call Sanofi-Aventis U.S. at
1-800-633-1610 or contact the FDA's MedWatch Safety Information and Adverse Event Reporting Program online, by phone at 1-800-332-1088, or by mailing the postage-paid FDA form 3500 or faxing it to 1-800-FDA-0178.
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desipramine hydrochloride