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FDA Confirms No Heart Risk From Heartburn Drugs
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Page: << Prev | 1 | 2 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.
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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.
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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 12/11/2007
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SOURCES: Dec. 10, 2007, teleconference with Paul Seligman, M.D., M.P.H., associate director, Office of Safety Policy and Communication, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Philip O. Katz, M.D., chair, gastroenterology, Albert Einstein Medical Center, Philadelphia; Dec. 10, 2007, news release, U.S. Food and Drug Administration; Dec. 10, 2007, news release, AstraZeneca
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