Citalopram hydrobromide (Celexa)
March 29, 2012
FDA announced changes to the product labeling of citalopram hydrobromide (Celexa® and generics), a selective-serotonin reuptake inhibitor (SSRI). Previous labeling for citalopram recommended doses up to 60 mg daily for improvement of depression in some patients, although doses greater than 40 mg did not show improved benefit in clinical trials. However, recent post-marketing reports and a clinical trial found a dose-dependent association between citalopram use and increased QT interval and cardiac arrhythmias, such as Torsades de Pointes. These arrhythmias are potentially fatal. Patients with existing heart conditions, such as congestive heart failure or bradyarrhythmias, or those with hypokalemia or hypomagnesemia are especially at risk for this effect.
Labeling changes were made on August 12, 2011 and March 27, 2012. The labeling changes for citalopram include updates to the adverse effects and dosing information sections. The adverse event information warns of the risk of potential QT interval prolongation and Torsades de Pointes. The new maximum dosing recommendation is 40 mg daily. Do not exceed 20 mg daily in patients with hepatic impairment, poor CYP 2C19 metabolism, or in patients greater than 60 years old. Additionally, patients taking CYP2C19 inhibitors such as cimetidine must not exceed a maximum daily dose of 20 mg. Citalopram is not recommended in patients with congenital long QT syndrome, bradycardia, recent myocardial infarction, or uncompensated heart failure, or with other medications that cause QT interval prolongation. Monitor electrocardiogram (ECG) if citalopram is deemed medically necessary and used in patients for whom it is not recommended. Discontinue citalopram in the event of persistent QTc greater than 500 ms. Additional recommendations for dosing citalopram include correcting potassium and magnesium levels before initiating therapy and monitoring electrolytes periodically, particularly in patients at risk for hypokalemia or hypomagnesemia.
Patients currently taking citalopram 60 mg should not stop this medication abruptly, but should consult their primary care provider to discuss treatment options. Report citalopram related adverse effects to the MedWatch program.
Additional information is available at the following links:
- MedWatch (March 28, 2012):
- Drug Safety Communication (March 28, 2012):
- MedWatch (August 24, 2011):
Updated: March 29, 2012; August 24, 2011; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.