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Norpramin Label Updated to Note Associatiation with Fatal Heart Attacks

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The label of the antidepressant Norpramin (desipramine hydrochloride tablets USP)  has been updated to include information regarding an association with sudden, fatal heart attacks in patients with irregular heartbeats.

Norpramin is a tricyclic antidepressant  that inhibits the reuptake of norepinephrine and serotonin and to a lesser extent dopamine.  It is used to treat depression, but has  not considered a first line treatment since the introduction of SSRI antidepressants.

The Norpramin label already warned of  other potential cardiac side effects, including hypertension, heart blocks, tachycardia, ventricular fibrillation and sudden death.  The current safety information for Norpramin also warns of a risk of increased suicidal thoughts in some patients.

According to a “Dear Healthcare Professional” letter issued by Sanofi-Aventis,  new Norpramin safety information in the “Warnings” section states that extreme caution should be used when this drug is given to patients who have a family history of  sudden death, cardiac dysrhythmias, and cardiac conduction disturbances.   The section also notes that seizures may precede cardiac dysrhythmias and death in some patients.

According to the letter, the “Overdosage” section of the Norpramin safety information has been updated to include a section that warns that taking too much of the drug has resulted in a higher death rate “compared to overdoses of other tricyclic antidepressants.”  Sanofi-Aventis also changed instructions to doctors in the event of an overdose of Norpramin.

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