Karyn R Fabo1, Ann Marie Nye1, Jane P Gagliardi1, Christopher R Dennis1, Andrew J Muzyk1. 1. Department of Pharmacy Practice, Campbell University College of Pharmacy and Health Sciences, Buies Creek (Drs Fabo, Nye, and Muzyk); Greenville Veterans Affairs Health Care Center, Greenville (Dr Fabo); Department of Family Medicine, East Carolina University, Greenville (Dr Nye); Department of Psychiatry and Behavioral Sciences, Duke University, Durham (Drs Gagliardi and Muzyk); and Vidant Medical Center, Greenville (Dr Dennis), North Carolina.
Abstract
OBJECTIVE: The US Food and Drug Administration (FDA) issued a warning stating that patients older than 60 years are not recommended to receive doses of citalopram exceeding 20 mg daily due to concerns of corrected QT (QTc) prolongation. The purpose of this study is to assess the impact of the FDA warning on prescribing patterns of citalopram in patients 60 years of age and older. METHOD: This is a retrospective cohort study of hospitalized patients 60 years of age and older prescribed citalopram from October 24, 2010, to August 24, 2011 and from November 24, 2011, to September 24, 2012. Records were examined for the presence of baseline risk factors for QTc prolongation and torsades de pointes. RESULTS: The issuance of an FDA warning was not associated with an observable change in prescribing patterns of citalopram. A total of 98.8% of patients had at least 1 risk factor for QTc prolongation. No significant difference in the total number of risk factors was seen between groups (P = .915). No differences were seen in risk factors prewarning and postwarning, except a higher percentage had left ventricular hypertrophy (P = .001) or history of syncope (P = .043) prior to the warning. More subjects were prescribed concomitant proarrhythmic medications (P = .009) after the FDA warning was issued. Similar percentages of each group were receiving daily dosages > 20 mg of citalopram (P = .600). CONCLUSIONS: The issuance of an FDA warning did not produce observable changes in prescribing patterns of citalopram. Modifiable risk factors and optimal dosing may be targets of interventions aimed at promoting safer use of citalopram.
OBJECTIVE: The US Food and Drug Administration (FDA) issued a warning stating that patients older than 60 years are not recommended to receive doses of citalopram exceeding 20 mg daily due to concerns of corrected QT (QTc) prolongation. The purpose of this study is to assess the impact of the FDA warning on prescribing patterns of citalopram in patients 60 years of age and older. METHOD: This is a retrospective cohort study of hospitalized patients 60 years of age and older prescribed citalopram from October 24, 2010, to August 24, 2011 and from November 24, 2011, to September 24, 2012. Records were examined for the presence of baseline risk factors for QTc prolongation and torsades de pointes. RESULTS: The issuance of an FDA warning was not associated with an observable change in prescribing patterns of citalopram. A total of 98.8% of patients had at least 1 risk factor for QTc prolongation. No significant difference in the total number of risk factors was seen between groups (P = .915). No differences were seen in risk factors prewarning and postwarning, except a higher percentage had left ventricular hypertrophy (P = .001) or history of syncope (P = .043) prior to the warning. More subjects were prescribed concomitant proarrhythmic medications (P = .009) after the FDA warning was issued. Similar percentages of each group were receiving daily dosages > 20 mg of citalopram (P = .600). CONCLUSIONS: The issuance of an FDA warning did not produce observable changes in prescribing patterns of citalopram. Modifiable risk factors and optimal dosing may be targets of interventions aimed at promoting safer use of citalopram.
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