Unintended Consequences of Adjusting Citalopram Prescriptions Following the 2011 FDA Warning

Electrocardiogram Monitoring After the Food and Drug Administration Warnings for Citalopram: Unheeded Alerts?

“…Previous research has found no greater cardiac mortality or ventricular arrhythmia in individuals taking high doses of citalopram, with some studies finding that QT prolongation with citalopram and other antidepressants has been modest . In our previous work, we found low rates of EKG monitoring (8.5%) in a university‐based outpatient primary care clinic in individuals (N=199) maintained on higher‐than‐recommended doses of citalopram after the FDA warnings . This low rate of EKG monitoring occurred despite a pharmacist intervention to alert prescribing providers to the warning .…”

“…However, these results are similar to previous results found outside the VA healthcare system demonstrating low overall rates of EKG monitoring (8.5%) after the FDA warnings and no increase in monitoring of individuals with previous cardiac risk factors at greatest risk of negative cardiac outcomes. 11 Studies evaluating the implementation of and responsiveness to FDA drug safety warnings have found that the warnings often have variable, and at times limited, effects in influencing changes in prescribing practices, 16,17 with one study that reviewed 200 black box warnings finding that more than 40% of individuals still received a potentially inappropriate medication after the black box warning. 18 Many factors may influence the decision of an individual provider to order an EKG after the citalopram safety warnings, including lack of clarity about who should undergo EKG monitoring, lack of health system incentives to adhere to the FDA warnings, provider knowledge regarding the drug safety warnings, and how concerned a provider is regarding a particular FDA warning.…”

“…9,10 In our previous work, we found low rates of EKG monitoring (8.5%) in a university-based outpatient primary care clinic in individuals (N5199) maintained on higher-than-recommended doses of citalopram after the FDA warnings. 11 This low rate of EKG monitoring occurred despite a pharmacist intervention to alert prescribing providers to the warning. 11 To our knowledge, no other studies have evaluated EKG monitoring since the citalopram drug safety warnings.…”

“…11 This low rate of EKG monitoring occurred despite a pharmacist intervention to alert prescribing providers to the warning. 11 To our knowledge, no other studies have evaluated EKG monitoring since the citalopram drug safety warnings.…”

QTc Time Correlates with Amitriptyline and Venlafaxine Serum Levels in Elderly Psychiatric Inpatients

“…Hutton et al concluded that further research is necessary to determine the association between clinical doses of citalopram (20-60 mg daily) and QT prolongation [30]. Thus, for clinical practice, comparable unbiased cardiac drug-risk gradings would be more helpful for optimal psychopharmacological treatment compared with some published data as the 2011 U.S. Food and Drug Administration warning [31].…”