FDA Warns about Celexa Side Effects


. By Heidi Turner

The US Food and Drug Administration (FDA) has issued a warning about potentially fatal Celexa side effects. Although these Celexa side effects are not linked to the reported risk of Celexa birth defects, they are serious enough that the FDA has made recommendations regarding doses of the medication.

On August 24, 2011, the FDA issued a warning that Celexa, known generically as citalopram hydrobromide, should not be used at doses greater than 40 mg per day. The announcement was made after the FDA learned of the possibility of abnormal changes in the electrical activity of the patient's heart when Celexa was used at doses of greater than 40 mg per day. Prior to the announcement, some patients were given doses of up to 60 mg per day.

Furthermore, the FDA noted that studies did not show a benefit in the treatment of depression when patients were given more than 40 mgs per day of the antidepressant.

According to the FDA's warning, the changes in the heart's electrical activity can lead to an abnormal heart rhythm, which can be fatal. That abnormal rhythm involves a prolonging of the QT interval and Torsade de Pointes. A post-marketing report based on a study of citalopram found that the increase in QT interval among patients on 20 mg a day was 8.5 ms compared with those on 60 mg per day, whose increase was 18.5 ms.

"As a result of this thorough QT study, FDA has determined that citalopram causes dose-dependent QT interval prolongation and should no longer be used at doses above 40 mg per day," the FDA warned (08/24/11).

Among those at highest risk of heart problems are patients with underlying heart conditions and those who have a predisposition to low levels of potassium and magnesium in the blood.

The FDA's recommendations include no longer prescribing Celexa at doses greater than 40 mg per day, not prescribing Celexa to patients with congenital long QT syndrome, and prescribing a maximum of 20 mg per day for certain patients. Patients who currently take citalopram should not stop or change their dose without speaking to a health care professional.

Celexa is in a class of drugs known as selective serotonin reuptake inhibitors (SSRIs). It is thought to work by increasing the amount of serotonin in the brain. SSRI medications have been linked in some studies to an increased risk of birth defects. One study, published in the Archives of General Psychiatry (07/04/11) suggests a link between a woman's use of SSRI antidepressants during the 12 months prior to delivering a baby and an increased risk of having a baby diagnosed with autism spectrum disorder.


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