Thursday, March 29, 2012

FDA Clarifies Dosing and Warning Recommendations for Celexa

The Food and Drug Administration (FDA) issued an announcement yesterday to clarify dosing and warning recommendations for the antidepressant Celexa (citalopram; also available in generic form). In August 2011, the FDA issued a Drug Safety Communication stating that citalopram should no longer be used at doses greater than 40 mg per day because it could cause potentially dangerous abnormalities in the heart's electrical activity. Citalopram use at any dose is discouraged in patients with certain conditions due to risk of QT prolongation, but because it may be important for some of those patients to use citalopram, the drug label has been changed to describe the caution needed when citalopram is used in such patients. The revised label also advises that the maximum recommended dose of citalopram should be 20 mg per day for patients who have hepatic impairment, are over age 60, are CYP 2C19 poor metabolizers, or are taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor, because these factors lead to increased blood levels of citalopram, increasing risk of QT interval prolongation and Torsade de Pointes.

Read the FDA Drug Safety Communication here.

In March of last year, the Pfizer subsidiary Greenstone announced a voluntary recall of some lots of its generic citalopram because some bottles labeled as citalopram actually contained the drug finasteride, used to treat benign prostatic hyperplasia. Read more about it in the Med Check column of Psychiatric News, here.

(Image: Brian A. Jackson/


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