Posted by Phillipa on December 3, 2009, at 0:12:24
For those who have relatives or themselves with any cardiac problems read below. Phillipa
From Medscape Medical News > Alerts, Approvals and Safety Changes > Medscape Alerts
Desipramine Increases Death Risk in Patients With Family History of Sudden Cardiac Death, Dysrhythmias
Deborah Brauser
December 2, 2009 The US Food and Drug Administration (FDA) and Sanofi-Aventis are warning healthcare professionals to use caution when prescribing the antidepressant desipramine hydrochloride (Norpramin) in patients with a family history of dysrhythmias or sudden cardiac death."The new safety information states that extreme caution should be used when this drugis given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances," according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.
The FDA and the manufacturer also warn that some patients may have seizures before cardiac dysrhythmias and death. Desipramine overdose is more likely to result in death than overdose with other tricyclic antidepressants, notes a company letter sent to healthcare professionals.
The "warnings" and "overdosage" sections of the drug's labeling are being changed to reflect these potential adverse events.
More information is available on the FDA's MedWatch Web site.
Adverse events and deaths related to desipramine should be reported to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852
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