FDA revises warnings on Celexa (citalopram)

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http://www.medpagetoday.com/Psychiatry/Depression/31896

 

FDA Softens Celexa Arrhythmia Warning

By John Gever, Senior Editor, MedPage Today March 28, 2012

 

The FDA has reworded warnings about potentially fatal arrhythmias associated with the antidepressant drug citalopram (Celexa), acknowledging that some patients may need the drug despite the risks.

 

Last August, the agency ordered numerous changes to the drug's label, including one stating that citalopram is contraindicated in patients with congenital long QT syndrome.

 

On Wednesday, however, the FDA announced that the label should say merely that the drug is "not recommended" in these patients because, as the agency explained, "it is recognized that there may be some patients with this condition who could benefit from a low dose of citalopram and who lack viable alternatives."

 

Other new revisions to the label included the following:

• Recommending electrolyte and/or electrocardiographic monitoring in patients at risk for arrhythmia if citalopram therapy is considered
• A maximum daily dosage of 20 mg for all patients older than 60
• Discontinuing the drug if QTc measurements are consistently greater than 500 ms

The label will continue to state that citalopram should be "avoided, if possible," in patients with or at risk for prolonged QT interval, including those prone to low blood levels of potassium and magnesium. Also, per the FDA's order of last August, the maximum dose in patients 60 and younger should be 40 mg/day.

 

QT interval prolongation can result in the fatal arrhythmia known as torsade de pointes, the FDA said. It said it had received postmarketing reports of such events associated with citalopram.

 

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The warnings do not apply to a related drug, escitalopram (Lexapro), which is the S-enantiomer of the racemic citalopram molecule. In announcing the changes to the citalopram label, the FDA noted new findings from clinical studies that escitalopram has much smaller, though still detectable, effects on the QT interval.

 

The maximum daily dosage of escitalopram should be 20 mg, the FDA said.