A safety warning issued in 2011 by the Food and Drug Administration over the dosage of an antibiotic backfired, leading to intensified depressive symptoms and more hospitalizations among patients whose conditions were previously stabilized on higher doses of the drugs, according to MedScape.
On August 24, 2011, the FDA issued the safety warning, stating that a daily dosage of citalopram should no longer exceed 40 mg a day due to a risk of dose-dependent QT interval prolongation. However, many clinicians cited a lack of evidence surrounding the incidence of life-threatening QT interval prolongation and noted the proven effectiveness of higher dosages of citalopram in clinical practice.
Thomas S. Rector, PharmD, PhD, from the Minneapolis VA Health Care System and the University of Minnesota (Minneapolis), analyzed the effects of the safety warning in a retrospective study of VA Health Administration's national EMR. Dr. Rector and his team of researchers compared rates of hospitalizations and mortality in an at-risk veteran population before and after the safety warning.
The analysis included 35,848 patients with an average citalopram dosage of 64 mg per day. After the safety warning, dosages were reduced for 18,407 patients. The dosages of the remaining 17,441 patients were not reduced.
The investigators discovered that all-cause hospitalizations or deaths were significantly increased after reductions in citalopram. A similar result was seen for hospitalizations for depression or all-cause death.
Dr. Rector believes that rapidly reducing dosages to under 40 mg per day may have triggered worsening symptoms of depression, PTSD, and other mental health disorders.
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