Health Canada Reviewing Celexa for Heart Issue

Health Canada announced that it is reviewing its prescription antidepressant, <"">Celexa (citalopram hydrobromide), for heart issues. The review followed study data suggesting that high doses of <"">Celexa (60 mg daily) adversely affect the heart’s electrical activity.

These electrical changes could potentially lead to serious and potentially fatal abnormal heart rhythms. Because of this, Health Canada is looking at all available data and reviewing the need for a dosing recommendation revision. Health Canada said it will follow-up with appropriate action based on its review, including collaborating with drug companies to update prescribing information. New safety information will be provided to healthcare professionals and the public when the review is concluded.

Citalopram is approved for the treatment of depression and is part of the class of drugs known as Selective Serotonin Reuptake Inhibitors (SSRIs). Canadian prescribing information recommends 20 mg/day of citalopram in adults; however, some patients who do not respond to this dose are typically prescribed from 40 to 60 mg/day. In Canada, citalopram is available in 10, 20, 30, and 40 mg tablets and is sold under the brand name Celexa as well as under a number of generic names, which all contain the “citalopram” in the name, with the exception of the generic “ran-citalo” and “CTP 30.”

Health Canada is advising patients with questions or concerns about citalopram to speak to their healthcare professional and warns against stopping or changing dosing for citalopram without first talking to a healthcare professional; stopping or changing dosing can lead to dizziness, feelings of agitation or anxiety, difficulty concentrating, abnormal dreams, nausea, or vomiting. Health Canada also advises patients to seek immediate care if an abnormal heartbeat, shortness of breath, dizziness, or fainting are experienced while taking citalopram and notes that patients may be at increased risks for developing an abnormal heart rhythm if diagnosed with an underlying heart condition, and/or have a history of low potassium or magnesium blood levels.

Drug labels, or “Product Monographs,” contain important prescribing and safety information for health professionals and patients, and are available at Health Canada’s Drug Product Database here.

As we’ve written, high doses of Celexa have been associated with potentially fatal abnormal heart rhythms, according to the U.S. Food & Drug Administration (FDA). In a recent Drug Safety Communication, the FDA said Celexa should no longer be used at doses greater than 40 mg per day. 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.

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,” which 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. In the U.S., the label for Celexa and its generic equivalents was revised to include the new drug dosage and usage recommendations, and information about the potential for QT interval prolongation and Torsade de Pointe.

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