FDA Safety Alert: Abnormal heart rhythms associated with high doses of citalopram hydrobromide

August 25, 2011

FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) 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.

FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) 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.

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.

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. 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. See the FDA Drug Safety Communication Data Summary for additional information. (See below.)

“Citalopram has only been approved by FDA for the treatment of depression,” said Timothy Hudd, BS, PharmD, RPh, AE-C, assistant professor of pharmacy practice, School of Pharmacy-Boston, Massachusetts College of Pharmacy, Boston. “The recommended dosing range for this indication is 20 mg to 40 mg. Doses above 40 mg have not been shown to consistently provide much benefit for this indication and are generally not recommended.”

However, Dr Hudd told Drug Topics, citalopram has a number of off-label uses such as treatment of obsessive-compulsive and panic disorders, “where the upper dosing limit is sometimes stretched to 40 mg to 60 mg. It is important to remember these doses have not been officially approved by FDA,” he said. “Both patients and clinicians should approach off-label prescribing with caution.”

Citalopram is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online:www.fda.gov/MedWatch/report.htm/
  • Download form or call (800) 332-1088 to request a reporting form, then complete and return it to the address on the preaddressed form or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:Celexa Safety Alert.