FDA Revises Warning For Antidepressant Citalopram.

MedPage Today (3/29, Gever) reports that the Food and Drug Administration (FDA) “has reworded warnings about potentially fatal arrhythmias associated with the antidepressant…citalopram (Celexa), acknowledging that some patients may need the drug despite the risks.” Last year, “the agency ordered numerous changes to the drug’s label, including one stating that citalopram is contraindicated in patients with congenital long QT syndrome.” However, yesterday 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.'”

“Patients at high risk include those with preexisting heart conditions (including congestive heart failure) and those prone to low levels of potassium and magnesium in the blood, the FDA said,” HealthDay (3/29, Preidt) reports. “At the time, the drug label was revised to include the new dosage limit as well as information about the potential for abnormal heart electrical activity and rhythms.” The current “recommendations note that Celexa in any dose should not be given to patients with certain conditions due to the risk of suffering these heart problems,” but “it may be important for some patients to take Celexa, so the label has been changed.”

Related Links:

— “FDA Softens Celexa Arrhythmia Warning,”John Gever, MedPage Today, March 28, 2012.

Posted in In The News.