Navigation Links
FDA Confirms No Heart Risk From Heartburn Drugs

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:
Related Image:
FDA Confirms No Heart Risk From Heartburn Drugs
(Date:11/24/2015)... ... November 24, 2015 , ... ... it comes to several aspects of orthopedic care. They have received recognition for ... and general orthopedic care. , Becker's Hospital Review selected hospitals for inclusion ...
(Date:11/24/2015)... ... November 24, 2015 , ... It takes only three to ... it is critical that the first impression be positive and reflects business values. If ... to buy anything or want to return. They will also share their thoughts about ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... LENR HHT Bolier Reactor System. Brillouin is the developer of renewable energy technologies ... low energy nuclear reactions (“LENR”), announced today that its WET™ and HHT™ Boiler ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... advisory organization, is pleased to welcome Winter-Dent & Company as its newest Partner ... day one to become a client's most trusted advisor regardless of whether that ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... States to support their local poison centers through donations on Tuesday, Dec. 1, ... calls it “a day that inspires people to collaborate in improving their local ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... , Nov. 24, 2015  Family Rentals, a ... announced the launch of their newly designed, mobile-responsive ... --> Logo ... --> --> Now, renting essential ... and vacation, just got a whole lot easier ...
(Date:11/24/2015)... --> --> Opportunities ... and PPAR Agonists cholesterol-lowering drugs market ? ... rates? This visiongain report shows you potential ... there. ,  ,Our 199-page report provides 153 tables, charts, ... industry and the future market prospects. Our new study ...
(Date:11/24/2015)... , Nov. 24, 2015  Boston Scientific Corporation (NYSE: ... Oppenheimer 26th Annual Healthcare Conference on December 8, in ... Susie Lisa , vice president, Investor Relations, will participate ... beginning at approximately 8:35 a.m. ET. --> ... in a 30-minute question-and-answer session with the host analyst ...
Breaking Medicine Technology: