ADR that result in revision of patient information
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| Canada: Antidepressant Cipralex (escitalopram): Updated information regarding dose-related heart risk |
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Health Canada is informing public 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:
1. Cipralex should not be used in patients with a heart condition known as congenital long QT syndrome, or in patients with QT interval prolongation.
2. 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).
3. 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.
4. 20 mg per day is still the maximum recommended dose for most other patients.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/../2012_63-eng.php
In Hong Kong, there are 17 registered pharmaceutical products containing escitalopram and are prescription-only medicines. In view of Health Canada’s recommendation, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board.
Ends/ Tuesday, May 08, 2012
Issued at HKT 14:00
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