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FDA Issues Dosage Cautions for Celexa

Filed March 29th, 2012 Laurie

In August 2011, the Food and Drug Administration issued a Drug Safety Communication (DSC) advising the medical community that they should stop using Celexa (citalopram) at doses greater than 40 mg per day because it could cause dangerous abnormalities in the electrical activity of the heart. Prolonged use of the drug is discouraged in patients with certain conditions because of the risk of QT prolongation.

The FDA is now clarifying dosing and warning information for the antidepressant Celexa (citalopram hydrobromide), which was already changed which stresses the importance of using abundant caution when prescribing the drug to dementia patients.

The agency has issues the following guidelines:

Citalopram is not recommended for use at doses greater than 40 mg per day because such doses cause too large an effect on the QT interval and confer no additional benefit.

Citalopram is not recommended for use in patients with congenital long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure.

Citalopram use is also not recommended in patients who are taking other drugs that prolong the QT interval.

The maximum recommended dose of citalopram is 20 mg per day for patients with hepatic impairment, patients who are older than 60 years of age, patients who are CYP 2C19 poor metabolizers, or patients who are taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor, because these factors lead to increased blood levels of citalopram, increasing the risk of QT interval prolongation and Torsade de Pointes.

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