• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Health Canada Reviews Data on Cardiac Events in Patients Taking Losec, Nexium

Posted on: Thursday, 9 August 2007, 15:02 CDT

OTTAWA (CP) - Health Canada says it's reviewing new preliminary safety information on serious cardiac events in patients using two popular prescription drugs for acid-related stomach problems.

The drugs, Losec and Nexium, are also used to treat and prevent ulcers in the stomach and small intestine. Health Canada stresses that the findings are preliminary and recommends that this "evolving safety information" should not change prescribing practices.

Patients taking the drugs should talk to their doctor before making any changes, as acid reflux disease can lead to other complications if left untreated.

Health Canada says drug maker AstraZeneca provided it with data in late May, after a preliminary analysis of two European clinical studies comparing patients who had anti-reflux surgery and those who took the drugs.

Patients on the drugs appeared to have more heart attacks and cardiac deaths than those who had the surgery, but Health Canada says many patients with cardiac events had risk factors prior to starting the pills.

The explanation for the differences in cardiac event rates is not yet clear because of methodological issues with the studies, the agency said.

"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," the agency said in a statement Thursday.

"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."

In the United States, the Food and Drug Administration said Thursday that it followed up on preliminary studies from AstraZeneca and found that they seemed skewed: Patients who underwent surgery were younger and healthier than those treated by drugs, suggesting the heart link may have been coincidence.

The agency then looked at 14 additional studies of the drugs and found no evidence of heart risks. In fact, in a few studies in which patients received either medication or a dummy pill, those who took the heartburn drugs actually had a lower incidence of heart problems.

The FDA plans to complete its probe within three months, but issued a public notice Thursday that it "does not believe that health-care providers or patients should change either their prescribing practices or their use of these products at this time."

Losec (omeprazole) and Nexium (esomeprazole) are not available without a prescription in Canada, and there are no over-the-counter drug products containing omeprazole or esomeprazole authorized for sale in this country.

Omeprazole is also sold under the labels of Apo-omeprazole and Ratio-omeprazole.

Gastroesophageal reflux disease is a condition that causes food, stomach contents and stomach acid to flow back up the esophagus, the tube that connects the mouth to the stomach. The condition can result in tissue damage in the esophagus.

Consumers who want more information can contact Health Canada at (613) 957-2991, or toll-free at 1-866-225-0709.

Source: Canadian Press

More News in this Category