August 24, 2011
SAFETY ALERT: FDA Warns of Arrhythmias with High Doses of CelexaThe FDA has notified healthcare professionals and patients that Celexa (citalopram hydrobromide; Forest) should no longer be used at doses >40mg/day because it can cause arrhythmias (eg, QT prolongation and torsades de pointes). Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to hypokalemia and hypomagnesemia.
Previously, the citalopram prescribing information (PI) stated that certain patients may require a dose of 60mg/day. Studies, however, did not show a benefit in the treatment of depression at doses >40mg/day. The citalopram Prescribing Information has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and torsades de pointes.
Celexa is indicated for the treatment of depression.
For more information visit www.fda.gov/Drugs/DrugSafety/ucm269086.htm.