Antidepressant Norpramin Receives Warnings for Heart Problems

French drug make Sanofi Avenis is warning healthcare professionals and patients about risks associated with its antidepressant Norpramin and heart problems. Patients who have a history of cardiac problems including cardio dysrhythmias and cardiac conduction disturbances should be cautious about prescribing or taking the antidepressant drug Norpramin.
The warning letter issued by Sanofi Aventis cautions healthcare providers about the risks associated with their antidepression drug. Excerpts of the letter include:
Under WARNINGS General, the addition of patients who have a family history of sudden death, cardiac dysrhythmias, or cardiac conduction disturbances; also the addition of a note that seizures precede cardiac dysrhythmias and death in some patients.
 Under OVERDOSAGE:
o This section was revised to read, “Overdose of desipramine has resulted in a higher death rate compared to overdoses of other tricyclic antidepressants.”
o Under Manifestations of Overdosage, addition of: “Early changes in the QRS complex include a widening of the terminal 40 msec with a rightward axis in the frontal plane, recognized by the presence of a terminal S wave in Lead 1 and AVL and an R wave in AVR.”
o Under Management, Gastrointestinal Decontamination, revised to read: “Activated charcoal should be administered to patients who present early after an overdose.”
o Under Management, Cardiovascular, revised to read: “A maximal limb-lead QRS duration widening to greater than 100 msec is a significant indicator of toxicity, specifically for the risk of seizures and, eventually, cardiac dysrhythmias. Serum alkalinization with intravenous sodium bicarbonate and hyperventilation (as needed) should be instituted in patients manifesting significant toxicity such as QRS widening. Dysrhythmias despite adequate alkalemia may respond to overdrive pacing, beta-agonist infusions, and magnesium therapy.”
o Under Management, CNS, “phenytoin” was replaced with “propofol” and the following was deleted: “Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.”
 Under DOSAGE AND ADMINISTRATION, Usual Adult Dose, deletion of: “Plasma
desipramine measurement would constitute the optimal guide to dosage monitoring.”
Any adverse effects connected to the use of Norpramin should be reported to the Food and Drug Administration.