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FDA Notice: High Doses of Celexa Can Cause Abnormal Heart Rhythms
FDA alerts health care providers that the antidepressant Celexa (citalopram hydrobromide; also marketed as generics) should no longer be used at doses greater than 40 mg per day. Data has demonstrated that doses greater than 40 mg per day can cause abnormal changes in the electrical activity of the heart that can lead to an abnormal heart rhythm, including Torsade de Pointes, which can be fatal. Further, while the citalopram drug label stated that certain patients may require a dose of 60 mg per day, studies have not shown that doses higher than 40 mg per day benefit the treatment of depression. FDA notes that patients with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood are at particular risk for developing the observed changes in the electrical activity of the heart (observed as prolongation of the QT interval of the electrocardiogram). The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes.
FDA advises that patients should not stop taking citalopram or change their dose without talking to their health care provider. Further, patients who are currently prescribed a dose greater than 40 mg per day should talk with their health care provider about changing the dose. Additional recommendations for health care providers and patients is available in an FDA Drug Safety Communication.
