FDA Warning Leads to Increased Hospitalization, Death

A safety warning issued by the US Food and Drug Administration (FDA) that advised against the prescription of the antidepressant citalopram at dosages higher than 40 mg/d has resulted in an increase in psychiatric hospitalizations among patients previously treated with higher doses of the drug, according to a recent study.

To examine the effects of this warning on rates of hospitalizations and mortality, the researchers conducted a retrospective study of electronic medical records from the Veterans Health Administration involving veterans who had citalopram prescriptions for 64 mg/d.
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Within 180 days of the safety communications being issued, 60% of the 35,848 patients in the at-risk cohort had filled prescriptions for citalopram ≤40 mg/d. Following dosage reductions, rates of all-cause hospitalizations and deaths significantly increased (adjusted hazard ratio 4.5), as did hospitalizations for depression and all-cause death (adjusted hazard ratio 2.2).

“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.”

—Michael Potts

Reference:
Rector TS, Adabag S, Cunningham F, Nelson D, Dieperink E. Outcomes of citalopram dosage risk mitigation in a veteran population [published online May 10, 2016]. Am J Psychiatry. http://dx.doi.org/10.1176/appi.ajp.2016.15111444.