High Doses of Citalopram Linked to Abnormal Heart Rhythms

The FDA is informing health care professionals and patients that the antidepressant citalopram hydrobromide, which is marketed as Celexa, should no longer be used at doses greater than 40 mg per day because higher doses of the drug cause QT interval prolongation that can lead to development of torsades de pointes, a potentially fatal abnormal heart rhythm.

The FDA said in an Aug. 24 safety announcement that patients with underlying heart conditions and those who are predisposed to hypokalemia and hypomagnesemia are at increased risk for developing torsades de pointes.

Furthermore, the agency said studies have shown no additional benefit in treating depression with doses higher than 40 mg per day. Citalopram is available in 10-mg, 20-mg and 40-mg tablets, as well as a 10-mg/5-mL oral solution.

The FDA said citalopram's drug label has been revised to include new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and torsade de pointes. Previously, the drug's label stated that some patients may require a dose of 60 mg per day.

The agency issued the following recommendations for physicians:

The FDA advised patients taking citalopram in doses greater than 40 mg per day to consult their physician. The agency also cautioned patients against stopping their use of the drug without consulting their physician because suddenly stopping citalopram can cause side effects. Patients also are advised to read the drug's medication guide.