FDA Clarifies Citalopram Warnings Linked to Heart Rhythm Abnormalities

The FDA is clarifying usage and dosing recommendations the agency issued last year for the antidepressant citalopram hydrobromide, which is marketed as Celexa and also is available in generic form.

The agency issued a warning in August, saying that the antidepressant should no longer be used at doses greater than 40 mg per day because higher doses of the drug cause QT interval prolongation that could lead to development of torsades de pointes, a potentially fatal abnormal heart rhythm.

In a March 28 drug safety communication, the FDA said it now has revised the drug label to include restated guidelines regarding QT interval prolongation and torsades de pointes issues, as well as new drug dosage and usage recommendations.

Several changes have been made to citalopram's packaging information:

In August, the FDA advised patients taking citalopram in doses greater than 40 mg per day to consult their physician and cautioned patients against stopping use of the drug without consulting their physician because suddenly stopping citalopram can cause withdrawal effects. Patients also were advised to read the drug's medication guide. Those cautions still stand, said the agency in this week's announcement, which also noted that patients should seek immediate care if they experience an irregular heartbeat, shortness of breath, dizziness or fainting while taking citalopram.

Physicians and patients are encouraged to report adverse events associated with citalopram use to the FDA's MedWatch program.