FDA: Users of Celexa (generic: citalopram hydrobromide) should no longer take doses any higher than 40 mg per day, due to dose-dependent risks of abnormal electrical activity of the heart, as well as potentially fatal heart rhythms.
Celexa Heart Risks: An Overview
August 24, 2011 — The FDA issued a Drug Safety Communication to warn doctors and patients of the possible fatal side effects of Celexa, when taken in dosages higher than 40 mg.
Recent studies have linked high doses of Celexa to abnormal electrical heart activity, which is also known as the prolongation of the QT interval (measure of time it takes for the heart muscles to contract and recover). Prolonged QT intervals are measured using an electrocardiogram (ECG or EKG). An EKG tests and checks for electrical activity of the heart.
Abnormal electrical activity is serious because it may lead to abnormal heart rhythms, including Torsades de pointes, which may be fatal. Torsades de pointes is a French term that means “twisting of the points” and is used to describe a rare and lethal form of ventricular tachycardia, characterized by an irregularly fast heart rhythm. Because the heart is beating so quickly, it causes the waves on an EKG to appear as if they are twisting. Torsades de pointes can occur without warning and causes less blood to pump to the brain, causing patients to faint. Because Torsades de pointes is so rare and requires an EKG for detection, it is very difficult to treat.
If untreated, Torsades de pointes episodes can change from lasting only for a minute to lasting longer. When this happens, it leads to a life-threatening condition called ventricular fibrillation, which causes the heart to beat so fast that it stops functioning all together. Without medical intervention, this can lead to permanent brain damage or even death.
Patients who are particularly at risk of developing abnormal electrical activity are those with underlying heart conditions and those predisposed to low levels of potassium and magnesium in the blood.
Celexa, also available in its generic form of citalopram, is one of the most popular antidepressants on the market and is a member of the selective serotonin reuptake inhibitors (SSRIs) family. SSRIs work by normalizing naturally occurring brain chemicals — in particular increasing the amount of serotonin in the brain. Celexa and other SSRIs are used to treat conditions including: major depression, bulimia nervosa, obsessive compulsive disorder and premenstrual dysphoric disorder (PMDD).
Contrary to previous information, research has found that there is no clinical benefit in patients receiving treatments in doses higher than 40 mg. Previously, the Celexa label stated that certain patients may benefit from a dose of 60 mg per day. This information has been proven inaccurate.
The label of Celexa has been changed, advising against 60 mg doses. It has also been changed to include warning about the increased risk of abnormal electrical heart activity and abnormal heart rhythms, including Torsades de pointes.
Celexa is currently available in 10 mg, 20 mg and 40 mg tablets.
In the past, Celexa has also been linked to increased risks of birth defects.
FDA Recommendations
The FDA issued this list of recommendations for patients and doctors:
- Citalopram should no longer be prescribed at doses greater than 40 mg per day.
- Citalopram should not be used in patients with congenital long QT syndrome.
- Patients with congestive heart failure, bradyarrhytmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes.
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