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  • FDA Date: 08/24/2011

    Celexa (citalopram hydrobromide) FDA Drug Safety Communication

    Abnormal Heart Rhythms Associated With High Doses of Celexa (citalopram hydrobromide)

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is informing healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day.

    Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day.

    Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG] can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.

    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.

    Healthcare professionals should be aware that:

    - Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day.

    - Citalopram should not be used in patients with congenital long QT syndrome.

    - Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes.

    - Hypokalemia and hypomagnesemia should be corrected before administering citalopram. Electrolytes should be monitored as clinically indicated.

    - Consider more frequent electrocardiogram (ECG) monitoring in patients with congestive heart failure, bradyarrhythmias, or patients on concomitant medications that prolong the QT interval.

    - 20 mg per day is the maximum recommended dose for patients with hepatic impairment, who are greater than 60 years of age, who are CYP 2C19 poor metabolizers, or who are taking concomitant cimetidine (Tagamet), because these factors lead to increased blood levels of citalopram, increasing the risk of QT interval prolongation and Torsade de Pointes.

    - No dose adjustment is necessary for patients with mild or moderate renal impairment.

    View the full FDA Drug Safety Communication on FDA.gov