VA Researchers Question FDA Antidepressant Warning

The U.S. Food and Drug Administration (FDA)
in 2011 and 2012 issued warnings that higher doses of the antidepressant citalopram hydrobromide increased the risk of two adverse cardiac outcomes—prolonged QT interval and torsade de pointes. Now, after studying records of nearly 1 million patients with depression, a group of Department of Veterans Affairs (VA) researchers “question[s] the continued merit of the warning.”

They compared low, medium, and high doses of citalopram with those another antidepressant, sertraline, that does not have an FDA cardiac-related warning. Adjusted results revealed that higher doses (40 mg/day) of citalopram were actually associated with lower risks of ventricular arrhythmia, all-cause mortality, and noncardiac mortality, compared with doses of 1 mg/day to 20 mg/day, they wrote in the June American Journal of Psychiatry. There was no increase in risk of cardiac mortality with the higher dose.

Patients prescribed sertraline recorded similar results, although without any associations with all-cause or noncardiac mortality.

“These findings raise questions regarding the continued merit of the FDA warning and provide support for the questions of whether the warning itself will cause more harm than good,” said Kara Zivin, Ph.D., of the VA’s National Serious Mental Illness Treatment and Evaluation Center and an assistant professor of psychiatry at the University of Michigan Medical School and colleagues.

For more in Psychiatric News about the FDA’s warning on citalopram, click here.

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FDA Cuts Dosage Level for Citalopram

The U.S. Food and Drug Administration (FDA) said that the antidepressant drug citalopram should no longer be prescribed at dosages above 40 mg per day because it can cause problems in the heart’s electrical system in some people with pre-existing heart disease.

People with prolongation of the QT interval may be prone to developing dangerously abnormal heart rhythms if they take higher doses. Dosages up to 60 mg per day were previously indicated by the FDA, although the higher dosage showed no added benefit in clinical trials involving depression treatment, said the FDA. Patients with underlying heart conditions and those with low blood levels of potassium and magnesium are at particular risk for developing prolongation of the QT interval.



The FDA notified clinicians and patients about the decision on August 24.



Read more about this issue in Psychiatric News at http://pn.psychiatryonline.org/content/46/10/32.1.full.


The FDA alert is posted at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm

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FDA Orders New Warning on Seroquel Label

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The FDA has required a new warning on the label of the atypical antipsychotic Seroquel (quetiapine) cautioning doctors about potential prolongation of the QT interval that may occur when above-recommended amounts of Seroquel are combined with specific drugs. The warning advised against the use of Seroquel in combination with certain antiarrhythmics, antipsychotics, antibiotics, and other drugs, prompted by notice of 17 post-marketing cases of induced QT prolongation. Seroquel's prior labeling had warned of the heart arrhythmia risk but hadn't mentioned other drugs that could interact with the antipsychotic. The revised label also raises caution about use by the elderly and people with heart disease.

Even without the new warning, Seroquel's label is many pages long. Read about recent concerns regarding "overwarning" about adverse events on drug labels in Psychiatric News at http://pn.psychiatryonline.org/content/46/14/2.2.full.