Navigation Links
FDA Confirms No Heart Risk From Heartburn Drugs
Date:12/10/2007

Preliminary studies had suggested possible problems with Prilosec and Nexium

MONDAY, Dec. 10 (HealthDay News) -- 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. Paul 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.



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; Paul 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


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. GAO Report Confirms: Medicare Underpays for Anesthesia Services; Nurse Anesthetists Assure Seniors Access to Safe Anesthesia Care
2. University of Nevada School of Medicine Professor Confirms Accuracy Through Validation Study Using the CSI Health Station Model 6K
3. Actavis Confirms its Patent Challenge of Kings Avinza(R)
4. Barr Confirms Patent Challenge of UROXATRAL(R)
5. Perrigo Confirms Filing for Generic Version of Mucinex(R) and Announcement of Lawsuit by Adams Respiratory
6. Use of Technology to Document Comorbid Conditions May Improve Reimbursement, Increase Documentation Accuracy Study Confirms
7. Newly Published Study in Leading Medical Journal Further Confirms the Brava Systems Non-Surgical Breast Enhancement Effectiveness
8. LUNA Pure Prevention Survey Confirms Breast Cancer Misconceptions
9. Barr Confirms Patent Challenge of Ritalin(R) LA
10. New Research Released at AHA Confirms Itamars PAT Technology to Diagnose Early Cardiovascular Disease
11. Survey Confirms Americans Have a True Blind Spot Regarding Their Eye Health - and the Real Danger of UV Rays
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Confirms No Heart Risk From Heartburn Drugs
(Date:1/24/2017)... ... January 23, 2017 , ... The January 2017 issue of the ... study on how outdoor behavioral healthcare (OBH) – also known as wilderness therapy – ... while experiencing an increased sense of purpose both during and after treatment. , ...
(Date:1/24/2017)... ... January 23, 2017 , ... ... a new plugin that allows sleep centers to automatically connect and initialize all ... a thin client browser plugin is quickly installed on first use and then ...
(Date:1/23/2017)... Alto, CA (PRWEB) , ... ... ... a provider of translation and localization services for life science companies, has ... and inspection organization, TÜV SÜD America. ISO 17100 is the globally recognized ...
(Date:1/23/2017)... ... 23, 2017 , ... Wooden and plastic balance boards have been around since at least the ... Board is the first and only balance board to use a patent-pending design featuring ... at the same time as well as skill-level adjustable for all ages and abilities. ...
(Date:1/23/2017)... Indiana (PRWEB) , ... January 23, 2017 , ... ... Center for Assisted Living (IHCA/INCAL), will serve as a healthcare industry expert at ... 23. The panel discussion, moderated by Inside Indiana Business host Gerry Dick, will ...
Breaking Medicine News(10 mins):
(Date:1/23/2017)... Stock-Callers.com today presents the following Generic ... CPRX ), Sophiris Bio Inc. (NASDAQ: SPHS ), ... Therapeutics Inc. (NASDAQ: AGRX ). These companies are ... late trade on Friday, January 20 th , 2017, with ... of health care companies in the S&P 500 also were ...
(Date:1/23/2017)... , January 23, 2017 The global  anxiety disorders and ... by 2025. The rising incidence of depression worldwide is anticipated to drive the ... resulted in the declining demand for antidepressants in the recent years. ... ... Grand View Research Logo ...
(Date:1/23/2017)... DIEGO and PALMA, Spain ... Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical company ... that the first patient has been enrolled in ... lead candidate, SNF472, for the treatment of cardiovascular ... (HD). Most ESRD patients, in the ...
Breaking Medicine Technology: