The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant Celexa" data-scaytid="1">Celexa (citalopram" data-scaytid="3">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.
Facts about Celexa (citalopram hydrobromide)
- Is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
- Thought to work by increasing the amount of serotonin in the brain.1
- Available as 10 mg, 20 mg, and 40 mg tablets. Also available as an oral solution (10 mg/5 mL).
Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) - see Data Summary below - 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.
Additional Information for Patients
- Do not stop taking citalopram or change your dose without talking to your healthcare professional. Stopping citalopram suddenly can cause unwanted side effects.
- If you are currently taking a citalopram dose greater than 40 mg per day, talk to your healthcare professional about changing your dose.
- Seek immediate care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking citalopram.
- If you are taking citalopram, your healthcare professional may occasionally order an electrocardiogram (ECG, EKG) to monitor your heart rate and rhythm. An ECG is a test that checks for problems with the electrical activity of your heart.
- Read the Medication Guide for citalopram carefully and discuss any questions you have with your healthcare professional
FDA has received post-marketing reports of QT interval prolongation and Torsade de Pointes associated with Celexa and its generic equivalents. In addition, FDA has evaluated the results of a thorough QT study assessing the effects of 20-mg and 60-mg doses of citalopram on the QT interval in adults. In this randomized, multi-center, double-blind, placebo-controlled, crossover study, 119 subjects received citalopram 20 mg per day (Day 9), citalopram 60 mg per day (Day 22), and placebo. Compared to placebo, maximum mean prolongations in the individually corrected QT intervals were 8.5 and 18.5 milliseconds (ms) for 20 mg and 60 mg citalopram, respectively. For 40 mg citalopram, prolongation of the corrected QT interval was estimated to be 12.6 ms.
As a result of this thorough QT study, FDA has determined that citalopram causes dose-dependent QT interval prolongation and should no longer be used at doses above 40 mg per day. Important safety information about the potential for QT interval prolongation and Torsade de Pointes with drug dosage and usage recommendations are being added to the package inserts of Celexa and its generic equivalents.