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Contrary to a contempo admonishing by the US Food and Biologic Administration (FDA), college doses of the antidepressant citalopram may not access the amount of cardiovascular complications and bloodshed accident afterwards all, new analysis suggests.
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Issued in August 2011, the FDA admonishing cautions that circadian doses of the medication college than 40 mg may advance to arrhythmias, including torsades de pointes.
However, a ample accomplice abstraction of abstracts from the Veterans Health Administration (VHA) on added than 600,000 individuals showed that, back compared with circadian doses alignment amid 1 and 20 mg, doses greater than 40 mg of citalopram were absolutely affiliated to a lower accident for ventricular arrhythmia and all-cause and noncardiac mortality.
"This abstraction provides affirmation on outcomes associated with citalopram...use in the better samples, to our knowledge, anytime analyzed," address Kara Zivin, PhD, abettor assistant of psychiatry at the University of Michigan Medical School in Ann Arbor and analysis investigator for the Department of Veterans Affairs (VA) in Ann Arbor, and colleagues.
"These allegation accession questions apropos the connected arete of the FDA admonishing and accommodate abutment for the catechism of whether the admonishing itself will account added abuse than good," they add.
The abstraction was appear in the June affair of the American Journal of Psychiatry.
No Systematic Assessment
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According to the researchers, the FDA accustomed citalopram in 1998, and it had been acclimated by added than 80 actor bodies in 60 countries aloof a year later. Its apparent asleep in 2004.
However, an FDA biologic assurance active was issued in August 2011 admonishing clinicians that "citalopram should no best be assigned at dosages aloft 40mg/day because of abeyant aberrant changes in electrical action of the heart."
In March 2012, as appear by Medscape Medical News, the FDA adapted the admonishing to acclaim that circadian doses greater than 20 mg should not be acclimated in adults earlier than 60 years.
Still, Dr. Zivin and colleagues agenda that these risks had not been systematically assessed.
"This is analytical to do because citalopram has been able-bodied acceptable by abounding patients over a connected time, is accessible in a bargain all-encompassing formulation, and is an antidepressant of best on abounding decree formularies."
In fact, the medication is 1 of 4 careful serotonin reuptake inhibitors (SSRIs) on the blueprint for the VHA.
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For the study, the advisers adjourned abstracts for the aeon from 2004 through 2009 from the VHA National Registry for Abasement (NARDEP) on both in- and outpatients who accustomed a decree for citalopram (n = 618,450) or for sertraline, a allegory medication not accountable to the FDA admonishing (n = 365,898). Added than 90% of both groups were men.
The NARDEP abstracts were affiliated to abstracts from the National Death Index, as able-bodied as to codes from the ninth and tenth revisions of the International Classification of Diseases (ICD-9 and ICD-10), to admeasurement analytic and bloodshed outcomes.
No Added Risk
Results showed that alone 1.1% of all patients who accustomed a decree for any dosage of citalopram had ventricular arrhythmia compared with 1.1% of those who accustomed sertraline.
Of all accommodating deaths that occurred during the abstraction period, 3.3% of deaths amid those application citalopram were due to a cardiac account vs 4% for those application sertraline.
The participants accepting dosages of citalopram greater than 40 mg/day had no decidedly added accident for ventricular arrhythmia or all-cause, noncardiac, or cardiac mortality.
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In fact, the aerial dosages were associated with lower accident for the aboriginal 3 measures compared with circadian doses amid 1 and 20 mg (ventricular arrhythmia: adapted hazard arrangement [HR], 0.68, 95% aplomb breach [CI], 0.61 - 0.76; all-cause mortality: HR, 0.94, 95% CI, 0.90 - .099; noncardiac mortality: HR, 0.90, 95% CI, 0.86 - 0.96).
Although lower risks for ventricular arrhythmia were begin for circadian doses of 21 to 40 mg compared with doses of 1 to 20 mg (HR, 0.80; 95% CI, 0.74 - 0.86), there were no differences amid the 2 dosage ranges in accident for all-cause mortality.
"The sertraline accomplice appear agnate findings, except there were no cogent associations amid circadian dosage and either all-cause or noncardiac mortality," address the investigators.
"Currently, clinicians and patients who apperceive allowances from high-dosage citalopram charge accomplish a accommodation amid adhering to the FDA admonishing and accessible deepening abasement if patients accept too low a dosage," they add.
"Given the backbone of the methods acclimated in our abstraction and the low likelihood of a absolute controlled trial, we catechism the connected arete of the warning."
The abstraction was accurate by grants from the US Department of Veterans Affairs (VA) and from the VA Health Analysis and Development Services. One of the board letters accepting served as a adviser to the Hazelden Foundation. The added abstraction authors accept appear no accordant banking relationships.
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