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Information Update – Antidepressant Cipralex (escitalopram): Updated information regarding dose-related heart risk

May 7, 2012

OTTAWA, May 7, 2012 /CNW/ – 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 notbe used in patients with a heart condition
            known as congenital long QT syndrome, or in patients with QT
            interval prolongation.

        --  Use of Cipralex isdiscouraged 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 themaximum recommended dose for patients who:
            o are 65 years of age or older, or
            o have liver problems, or
            o 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

Related Health Canada Web content:

This communication is further to a Health Canada safety review that also
included the drug Celexa (citalopram), a prescription antidepressant
chemically similar to Cipralex (escitalopram). Health Canada together
with Lundbeck Canada Inc., the manufacturer of Cipralex and Celexa,
previously communicated on updates to the drug label for Celexa
regarding this dose-related heart risk, and that the need to update the
prescribing information for Cipralex was under evaluation:

        --  Celexa (citalopram) - Association with abnormal heart rhythms -
            Lundbeck Canada Inc.

                      For Health Professionals
                      (January 25, 2012)

                      For the Public (January 30, 2012)

Health Canada also communicated it was reviewing citalopram safety:

        --  Information Update (October 13, 2011):
            Citalopram: Health Canada reviewing dose-related heart risk

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SOURCE Health Canada


Source: PR Newswire