FDA Confirms No Heart Risk From Heartburn Drugs

MONDAY Dec. 10, 2007 -- A U.S. government review of the popular heartburn drugs Prilosec and Nexium found no evidence of increased heart risks, health officials said Monday.

The announcement followed a three-month safety review after reports of possible heart risks emerged from two preliminary studies. But detailed data from both studies, plus another 14 studies, showed no heightened risk associated with long-term use of the drugs, U. S. Food and Drug Administration officials said.

Dr. Paul Seligman, associate director of the FDA's Office of Safety Policy and Communication at the Center for Drug Evaluation and Research, told reporters that the agency "had completed our safety review, and our current assessment is that studies do not show a risk for heart attack or heart-related problems."

In a prepared statement released earlier in the day, the FDA also said: "Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect."

And it added, "FDA recommends that health-care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs."

Dr. Philip O. Katz, chairman of gastroenterology at Albert Einstein Medical Center in Philadelphia, agreed that these drugs are safe and that patients shouldn't hesitate to use them.

"This is altogether good news," Katz said. "It is reassuring to physicians and the public, who are using these drugs on a widespread basis, that this is not deemed to be an issue."

Both drugs are made by the British pharmaceutical company AstraZeneca. In May, the company gave the FDA findings from two small, preliminary trials that were designed to test the effectiveness of the drugs, compared with surgery, for severe gastroesophageal reflux disease (GERD).

During the trials, some cardiac "events" were seen among study participants, hinting that long-term use of Prilosec and Nexium could increase the risk of heart attack, heart failure and heart-related sudden death, the FDA said at the time.

Because of these concerns, AstraZeneca gave the FDA more detailed data from the two initial studies as well as findings from 14 other studies -- one 14 years in length -- that compared the drugs with a placebo.

The more complete data showed that patients taking Prilosec had a lower risk of heart problems than patients taking a placebo. And findings from the ongoing Nexium trial found no difference in heart problems between patients taking the drug and those undergoing surgery for GERD, the FDA statement said.

In a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."

However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.

Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.

AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.

Prilosec is also available over-the-counter to treat frequent heartburn.

More information

For more on GERD, visit the U.S. National Institute of Diabetes and Digestive and Kidney Diseases.

Posted: December 2007


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