Celexa heart rhythm warnings are being revised, according to the U.S. Food and Drug Administration (FDA). The agency said it is clarifying dosing and warning recommendations for the antidepressant.
Celexa (citalopram hydrobromide) is also available in generic form and all are in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
In August 2011, the FDA issued a Drug Safety Communication (DSC) stating that Celexa and its generic counterparts should not be used at doses in excess of 40 mg daily over potential and dangerous abnormalities in the electrical activity of the heart. Celexa or citalopram use, at any dose, is discouraged in patients with certain conditions over risks for QT prolongation and is not recommended for use in patients with congenital long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure. Use is also not recommended in patients taking other drugs that prolong the QT interval
It may be important for some of these patients to use citalopram; therefore, the drug label has been changed to describe the particular caution that needs to be taken when citalopram is used in such patients.
The revised drug label also describes lower doses that should be used in patients who are over 60 years of age and also states that the maximum recommended dose of citalopram is 20 mg per day for patients with hepatic impairment; patients older than 60 years of age; patients who are CYP 2C19 poor metabolizers; or patients taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor, because these factors lead to increased blood levels of citalopram, increasing the risk of QT interval prolongation, and Torsade de Pointes.
As we’ve written, high doses of Celexa have been associated with potentially fatal abnormal heart rhythms, according to the FDA. In the U.S. Celexa is available as 10 mg, 20 mg, and 40 mg tablets; as an oral solution (10 mg/5 mL); and in generic versions.
We’ve also previously written that 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.
Prolongation of the QT interval involves changes to the electrical activity of the heart and 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.
