Outcomes of Citalopram Dosage Risk Mitigation in a Veteran Population.

Rector TS, Adabag S, Cunningham F, Nelson D, Dieperink E. Outcomes of Citalopram Dosage Risk Mitigation in a Veteran Population. The American journal of psychiatry. 2016 Sep 1; 173(9):896-902.

Related HSR&D Project(s)

• IIR 12-363 – Changes in VA Practices after a National Medication Safety Bulletin

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Abstract:

OBJECTIVE: A public safety communication issued by the Food and Drug Administration declared that citalopram dosages exceeding 40 mg/day were no longer considered safe because of a newly recognized risk of dosage-dependent QT interval prolongation. The authors compared the incidence of hospitalizations and mortality when higher dosages of citalopram were or were not reduced to = 40 mg/day. METHOD: National electronic medical records compiled by the Veterans Health Administration were used to conduct a retrospective study of a population filling citalopram prescriptions for more than 40 mg/day when the safety communication was first issued in August 2011. Hospitalizations and mortality after dosages of citalopram were or were not reduced to = 40 mg/day were compared using multivariable Cox regression. RESULTS: The at-risk cohort of 35,848 veterans (mean age, 58 years [SD = 11]; 92% male) had citalopram prescriptions for 64 mg/day (SD = 8.3), on average. Within 180 days after the safety communication was issued, 60% had filled prescriptions for = 40 mg/day. All-cause hospitalizations or deaths were found to significantly increase after dosage reductions (adjusted hazard ratio = 4.5, 95% CI = 4.1-5.0), as were hospitalizations for depression or all-cause death (adjusted hazard ratio = 2.2, 95% CI = 1.8-2.6). Mortality did not decline (adjusted hazard ratio = 1.0, 95% CI = 0.8-1.3), and neither did hospitalizations for arrhythmias or all-cause deaths (adjusted hazard ratio = 1.3, 95% CI = 1.0-1.7). CONCLUSIONS: Reduction of prescribed citalopram dosages to a new safety limit was associated with a higher rate of hospitalization in a large patient population who had been treated with substantially higher dosages. Stipulating a safety limit for citalopram dosages before the benefits and risks of doing so were firmly established appears to have had unintended clinical consequences.