2011-134
October 13, 2011
For immediate release

OTTAWA - Health Canada is reviewing the heart-related safety of the prescription antidepressant citalopram. The review is in light of new study data suggesting that high doses (60 mg/day) can affect the electrical activity of the heart. The changes in electrical activity could potentially lead to serious, possibly fatal abnormal heart rhythms.

Health Canada is currently reviewing the available data and assessing the need for revised dosing recommendations and will take appropriate action based on the outcome of our review, including working with the companies to update the prescribing information. New safety information will be communicated to healthcare professionals and the public as soon as possible, once the review is complete.

Citalopram is used to treat depression and belongs to a family of drugs known as SSRIs (Selective Serotonin Reuptake Inhibitors). The current Canadian prescribing information recommends 20 mg/day of citalopram in adults. Some people who have not responded to this dose are prescribed 40 or even 60 mg/day.

In Canada, citalopram is available in 10, 20, 30, and 40 mg tablets. It is sold under the brand name Celexa and under several generic names (all of which contain "citalopram" in the name, except the generic products "ran-citalo" and "CTP 30").

Patients with questions or concerns about citalopram should talk to their healthcare professional. Do not stop taking citalopram or change your dose without first talking to your healthcare professional, as this can cause side effects such as dizziness, feelings of agitation or anxiety, difficulty concentrating, abnormal dreams, nausea or vomiting.

Seek immediate care if you experience an abnormal heartbeat, shortness of breath, dizziness, or fainting while taking citalopram. You may be at a higher risk of developing an abnormal heart rhythm if you have an underlying heart condition, and/or you have a history of low levels of potassium or magnesium in the blood.

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 report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• Internet: www.healthcanada.gc.ca/medeffect
• Mail (Get a postage-paid label):
  Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701E
  K1A 0K9

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