Lexapro Heart Rhythm Problems Draw New Warnings in Canada

Health Canada has announced new warnings about a dose-related risk of abdnormal hearth rhythms from Lexapro, which is marketed as Cipralex in that country.

Lexapro contains the active pharmaceutical ingredient escitalopram, which is used to treat depression and belongs to the popular family of antidepressants known as serotonin reuptake inhibitors (SSRI).

According to information released today by Health Canada, labeling for the Canadian version of the drug, Cipralex, will be updated based on clinical trial data that have shown escitalopram may cause electrical changes in the heart, known as QT interval prolongation, which could lead to serious and potentially life-threatening abnormal heart rhythms.

The risk of these heart rhythm problems from Lexapro and Cipralex appears to be dose-related, according to Health Canada, meaning that that the risk increases as the dosage increases.

New warnings about the risk of QT interval prolongation will be added to the label of Cipralex in Canada, as well as recommendations that the drug should not be used by individuals with a heart condition known as congenital long QT syndrome or with known QT interval prolongation. According to the warnings, use of the antidepressant should also be discouraged among individuals who are also taking other drugs that are known to prolong QT interval, such as certain medications to treat heart rhythm problems, certain antipsychotics, antidepressants, opioid painkillers and some medications prescribed to treat infections.

The maximum recommended dose has been limited to 10mg per day for certain at-risk patients, such as those 65 years old or older, with known liver problems or taking the heartburn drugs omeprazole or cimetideine, which may increase the blood level of escitalopram. For most other patients, the recommended maximum dose in Canada remains 20 mg per day.

Escitalopram was introduced in the United States in August 2002, under the brand name Lexapro, for treatment of major depression and generalized anxiety disorder. The medication has similar pharmacology to citalopram, which is marketed under the brand name Celexa in the United States.

In August 2011, the FDA issued a drug safety communication warning that side effects of Celexa may cause abnormal heart rhythms at high doses.