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FDA Revises Label to Protect Consumers' Hearts


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FDA Revises Label to Protect Consumers' Hearts

The U.S. Food and Drug Administration has ordered the makers of the antidepressant Celexa to revise the maximum recommended dose on its drug labels.

Following post-market reports and the results of a clinical trial that showed patients taking the previously recommended 60 milligrams per day were at increased risk of potentially fatal abnormal heart rhythms, the federal agency reduced the dosage to 40 milligrams.

Dr. Westby Fisher, director of cardiac electrophysiology at NorthShore University HealthSystem in Evanston, Illinois, tells NPR that high doses of citalopram, a chemical found in Celexa, can lead to "QT interval."

In addition to lowering the recommended dosage on the label, the FDA mandated that the drug packaging also includes a warning label about the potential heart risk. The regulations will also apply to generic versions of the antidepressant.

"Most patients are treated with lower doses of Celexa," Sandy Walsh, FDA spokesperson said, according to CNN. "But we issued the safety communication today [Wednesday] to make sure doctors and patients have the most up-to-date information possible to make treatment decisions."