FDA Adds More Warnings for Celexa (Citalopram)

On March 28, 2012, the FDA released a new list of dosing and use recommendations for Celexa. The new revisions state that the drug should not be given to patients with certain medical histories related to heart problems, and that the dosage of Celexa should be reduced to half of what it currently is to avoid such problems.

Celexa, or citalopram hydrobromide is an antidepressant in the same family as Zoloft and Prozac that is believed to work by increasing the amount of serotonin in the brain. The drug is in a group of medicines called selective serotonin reuptake inhibitors, or SSRIs.  Celexa has been found to change the electrical activity of the heart. Doses larger than 40mg a day could create a lengthening of the QT interval—a measure of time in the heart’s electrical system—that could lead to an abnormal and potentially fatal heart arrhythmia called Torsade de Points, or even cause death.

What Changed This Time?

The latest FDA additions to the warning labels of Celexa include a new list of recommendations. New recommendations include limiting the drug dosage to 40mg or less per day. Patients who are older than 60, have liver problems, or who are already taking inhibitors or other drugs that already lengthen the QT interval should not take more than 20mg per day. These factors increase the level of Celexa in the blood, which can increase the risk of a long QT interval and lead to Torsade de Points. Citalopram should be discontinued in patients whose QT interval measurements are consistently above 500ms.

Which Patients Are at Risk According to the New Recommendations?

Patients taking Celexa with standing heart conditions or congenital QT interval problems are shown to be the most at-risk, as well as people who have naturally low potassium and magnesium levels. For these particular patients, doctors do not recommend Celexa. Patients who are particularly at risk for these kinds of QT elongation problems must have both ECG and electrolyte monitoring while taking citalopram to avoid the risks of tachycardia, Torsade de Points, or in some cases, fatality.

What Should People Do in Response to This?

Despite these revisions, doctors tell patients not to panic. Those who are currently taking Celexa are cautioned against abruptly stopping their treatment in response to this latest medication warnings amendment. Patients who have a personal or family history of cardiac issues, and those who have questions about Celexa treatment, should consult their doctors and psychiatrists. When discussing whether Celexa treatment is right for them, it is important for patients to mention if they have had any instances of fainting.

This is not the first time that the FDA changed the dosage recommendations for Celexa; the recommendations were also altered on August 12, 2011 and March 27, 2011. In both of these revisions, the FDA reduced the recommended dosage of Celexa. These new changes will affect a significant number of Celaxa users. According to research, approximately 72 million people were using Celexa in 2011 alone, and only 6% of that total were using doses of the drug below 40mg.