April 20, 2012

Warning Label Changes for Antidepressant

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Robert Carlson, M.D By:

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Celexa at high doses may affect heart rhythms

(dailyRx News) The U.S. Food and Drug Administration (FDA) updated the warning labels on Celexa, an antidepressant. The new label warns against increased risk for changes in heart rhythms for some patients using higher doses of the drug.

New FDA labels warns against the use of 40 mg/day doses of the Celexa. They recommend that patients who are at risk for disrupted heart rhythms should not exceed a 20 mg/day dose of Celexa.

"Talk to your psychiatrist about your antidepressant risks and benefits"

Celexa (citalopram) is an antidepressant approved by the FDA to treat major depression. In March, 2012, the FDA issued an updated warning label for Celexa in both the oral solution and tablet forms. 

The new label warns about altered heart rhythms, known as QT prolongation. The FDA recommends that doses of Celexa stay below 40 mg/day for patients already at risk for QT prolongation.

QT prolongation is a disruption of the electrical signals of the heart that can result in dangerous effects, such as ventricular fibrillation and death. Certain drugs can cause QT prolongation, and people with poor liver function are also at risk for QT prolongation.

Celexa taken at 40 mg/day increased the risk of experiencing QT prolongation in some patients. The FDA warns that Celexa should be avoided for patients taking some drugs known to cause QT prolongation, such as some antipsychotics, antiarrhythmic medications, and certain antibiotics. 

The new label also recommends that people with decreased liver function should not exceed 20 mg/day doses of Celexa because the higher dose increases the risk of QT prolongation.  Heart and electrolyte monitoring are recommended for patients who may be at risk for QT prolongation.

The FDA states that doctors and patients should discuss individual risks and benefits of Celexa.

The updated warning label information was posted on the FDA website as part of the FDA’s MedWatch program that monitors drug safety and adverse events.
 

Medications: 
Celexa

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Reviewed by: 
Robert Carlson, M.D
Review Date: 
April 18, 2012

Last Updated:
April 20, 2012