2008-34
February 27, 2008
OTTAWA - Further to its Information Update dated August 9, 2007, Health Canada is informing Canadians of the results of its review of safety information for Losec (omeprazole) and Nexium (esomeprazole), two prescription drugs used to treat conditions where a reduction of gastric acid secretion is required, such as ulcers and reflux. In Canada, omeprazole is also sold in generic form as Apo-omeprazole, Ratio-omeprazole and Sandoz-omeprazole. Esomeprazole is only sold under the trade name Nexium.
Nexium (esomeprazole)
Based on its review of the data available at this time, Health Canada has concluded that there is no evidence supporting an increased cardiovascular risk associated with the long-term use of esomeprazole.
The Department will continue to monitor safety issues related to esomeprazole by conducting further analysis of ongoing long-term studies as this data becomes available.
Losec (omeprazole)
After a thorough analysis, based on the data available to us at this time, we are unable to definitively conclude if there is a potential for increased cardiovascular risk associated with the long-term use of omeprazole. We will continue to evaluate should more conclusive data become available, and will advise Canadians if any further regulatory actions are required.
Health Canada will be working with manufacturers to include current study data in the Canadian Product Monographs for Losec and other omeprazole-containing drugs.
In light of this information, patients taking omeprazole or esomeprazole should not make any changes to their medication unless discussed with their doctor, as ulcers and reflux can lead to other complications if left untreated.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to these health products, please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail: CanadaVigilance@hc-sc.gc.ca
The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect area of the Health Canada Web site.
- 30 -
Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
1-866 225-0709
