Archived - Health Canada reviewing new safety information on cardiac events in patients taking Losec (omeprazole) or Nexium (esomeprazole)

Starting date:

August 9, 2007

Posting date:

August 9, 2007

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public

Identification number:

RA-110002178

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  Media enquiries
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  Public enquiries

Health Canada is advising consumers that it is currently reviewing new preliminary safety information regarding serious cardiac events in patients using Losec (omeprazole) and Nexium (esomeprazole), two prescription drugs used to treat acid-related stomach disorders. Losec and Nexium are also used to treat and prevent ulcers in the stomach and small intestine. Omeprazole is also sold in Canada under the labels of Apo-omeprazole and Ratio-omeprazole There are no over-the-counter drug products containing omeprazole or esomeprazole authorized for marketing in Canada.

Since May 29, 2007, AstraZeneca Canada Inc. has provided a large amount of data and information to Health Canada and other regulatory authorities worldwide based on a preliminary analysis of two long-term European clinical studies. These studies examined the effectiveness of Losec and Nexium in preventing the return of reflux symptoms (heartburn and/or regurgitation) in patients with gastroesophageal reflux disease (GERD), compared to patients who underwent anti-reflux surgery.

GERD is a condition that causes food, stomach content and stomach acid to frequently flow back up the esophagus, the tube that connects the mouth to the stomach. The condition could result in severe reflux esophagitis (tissue damage in the esophagus) which, if left untreated, may lead to further complications.

What Health Canada Knows

From these studies it was observed that patients using Losec or Nexium may have experienced more heart attacks or cardiac deaths than patients who had the surgery. Many patients who developed cardiac events had risk factors prior to beginning treatment.

The findings from the two clinical studies are preliminary and the explanation for the differences in cardiac event rates is not yet clear because of methodological issues with the studies. The data being reviewed by Health Canada comes from a study completed at 12 years, comparing treatment with omeprezole to surgery in patients with severe GERD. Another ongoing study comparing esomeprazole to surgery has five-year follow-up information on patients. The study designs did not provide for a clear definition of cardiac problems or an adequate follow-up of patients. While both studies include some safety data, it is difficult to evaluate this data because of the way it was collected, reported and documented.

At this point in time, Health Canada's preliminary review suggests that the evidence provided does not confirm the existence of a possible cardiovascular risk. Health Canada will complete its analysis of the new information by the end of the year and will advise Canadians of its conclusions and any resulting recommendations at that time.

Pending the completion of a detailed analysis of these two studies, it is recommended that this preliminary and evolving safety information should not change prescribing practices of health professionals at this time.

Patients taking Losec or Nexium should consult with their doctor before making any change to their medication, as GERD can lead to other complications, if left untreated.

To report a suspected adverse reaction to this health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345

Facsimile: 1-866-678-6789

CADRMP

Marketed Health Products Directorate

Ottawa, Ontario, AL 0701C

K1A 0K9

Email: cadrmp@hc-sc.gc.ca

The CADRMP 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.

Media enquiries

Alastair Sinclair

Health Canada

(613) 957-1803

Public enquiries

(613) 957-2991

1-866 225-0709