Safety Alerts & Recalls

What does this mean?

This new warning information is a reminder to regularly review with your doctor the benefits of how well Desipramine is working for you and the side effects and potential serious risks of this medicine. If you have a history of heart disease, seizures, or a family member with a history of sudden death, arrhythmias or cardiac conduction problems and have not discussed how this history may affect your risk of serious side effects from Desipramine, please make an appointment with your doctor as soon as possible to review your benefits and risks from this medicine.

If you have any questions about this safety alert or if you think you are experiencing side effects from Desipramine, please follow up with your doctor.

Changes to the Warnings Sections of Norpramin (desipramine) Prescribing Information

Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings section of the Prescribing Information for Norpramin (desipramine) regarding the risk of heart problems and seizures. These updated warnings now state: 1) In general, Norpramin should be used with extreme caution in patients with heart disease because of the possibility of conduction defects, arrhythmias (abnormal heart rhythms), tachycardias (fast heart rate), strokes, and acute myocardial infarction. The updated safety information now also warns that extreme caution should be used when this drug is given to patients who have a family history of sudden death, arrhythmias, and cardiac conduction disturbances.

2) Norpramin has been shown to lower the seizure threshold and should be used with extreme caution in patients with a history of seizures. The updated prescribing information now warns that seizures have occurred before arrythmias and death in some patients who have used Norpramin.

Norpramin is indicated for the treatment of depression. These new warnings also apply to desipramine, the generic name for Norpramin.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-12-03
Last Updated: 2010-12-06

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