Health Canada announces labelling update for Cipralex

Health Canada is informing Canadians of a labelling update for the prescription drug Cipralex (the brand name of the drug escitalopram) regarding a dose-related risk of abnormal heart rhythms. Cipralex is used to treat depression and belongs to a family of drugs known as Selective Serotonin Reuptake Inhibitors (SSRIs).

Clinical trial data has shown that Cipralex can cause electrical changes in the heart known as QT interval prolongation. These electrical changes can lead to abnormal heart rhythms, which can be life threatening. The risk is dose-related, meaning that the risk increases as dosage increases.

A warning on the dose-related risk of QT interval prolongation has been added to the drug label for Cipralex, as well as revised prescribing and dosing recommendations:

• Cipralex should not be used in patients with a heart condition known as congenital long QT syndrome, or in patients with QT interval prolongation.
• Use of Cipralex is discouraged in patients who are also taking drugs that prolong QT interval or that decrease electrolyte levels in the body. Examples of drugs that affect QT interval include: drugs used to treat heart rhythm problems, certain antipsychotics, certain antidepressants, opioid painkillers and certain drugs used to treat infections. Examples of drugs that may affect electrolyte levels include: diuretics (water pills) and laxatives (including enemas).
• 10 mg per day is the maximum recommended dose for patients who:
  • are 65 years of age or older, or
  • have liver problems, or
  • are taking the heartburn drugs omeprazole or cimetidine which can increase the blood level of Cipralex.

20 mg per day is still the maximum recommended dose for most other patients.

What patients should do:

Before starting Cipralex, tell your healthcare professional: if you have had any heart problems, what other medications you are taking (including natural health products), if you have a history of fainting, if you have a history of electrolyte disturbances (low levels of potassium, magnesium or calcium in the blood) or conditions that might lead to electrolyte disturbances such as vomiting, diarrhea, dehydration, and if you are following a strict diet.

Consult with your healthcare professional if you are considering stopping or reducing your dose, as abruptly stopping or reducing your dose may cause side effects such as dizziness, unusual dreams, electric shock sensations, agitation, anxiety, difficulty concentrating, migraine, headache, shakiness, sweating, nausea, or vomiting.

If you experience any symptoms of abnormal heart rhythms such as heart palpitations, dizziness, fainting, or seizures while taking Cipralex, contact your healthcare professional immediately.

Patients with questions or concerns about their Cipralex treatment should speak to a healthcare professional.

Drug labels, or "Product Monographs," contain important prescribing and safety information for health professionals and patients, and are available by search of Health Canada's Drug Product Database.

How to report side effects to health products to Health Canada

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax