High doses of the antidepressant <"http://www.yourlawyer.com/topics/overview/celexa">Celexa (citalopram hydrobromide) have been associated with potentially fatal abnormal heart rhythms, the U.S. Food & Drug Administration (FDA) has warned. In a Drug Safety Communication issued yesterday, the FDA said Celexa should no longer be used at doses greater than 40 mg per day.
Celexa belongs to a class of drugs known as <"http://www.yourlawyer.com/topics/overview/ssri-antidepressants-birth-heart-defects-side-effects-lawsuit">selective serotonin reuptake inhibitors (SSRIs). It is available as 10 mg, 20 mg, and 40 mg tablets, and as an oral solution (10 mg/5 mL). It is also available in generic versions.
Previously, the Celexa label stated that certain patients may require a dose of 60 mg per day. However, studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day, the FDA said.
According to the agency’s communication, data from post-market surveillance and a clinical trial indicated that Celexa at the 60 mg/day dose was associated with unsafe changes to the electrical activity of the heart, a condition known as “prolongation of the QT interval.” This can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium (hypokalemia) and magnesium (hypomagnesemia) in the blood.
Based on the trial data, the agency estimated that a 40-mg-per-day dose of Celexa would be safe. The FDA also noted that hypokalemia and hypomagnesemia should be corrected before administering Celexa, and that electrolytes should be monitored as clinically indicated. Healthcare professionals have been advised to consider more frequent electrocardiogram (ECG) monitoring in Celexa patients with congestive heart failure, bradyarrhythmias, or patients taking other medications that prolong the QT interval.
The label for Celexa and its generic equivalents has now been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointe. Patients taking Celexa in doses greater than 40 mg/day should speak to their doctors about changing their dose. Patients should not stop taking Celexa or change their dose without talking to their doctor first, as this can lead to serious side effects.
Celexa patients should seek immediate medical attention if they experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking Celexa.