Chrome 2001
.
Aetna Intelihealth InteliHealth Aetna Intelihealth Aetna Intelihealth
 
.
. .
.
Chrome 2001
Chrome 2001
Health News Health News
.
FDA Panel Sees No Heart-Safety Advantage With Naproxen
February 11, 2014

 

TUESDAY, Feb. 10, 2014 (HealthDay News) -- The science isn't convincing enough to say that naproxen -- the key pain reliever in Aleve -- is safer for the heart than other popular anti-inflammatory drugs such as ibuprofen (Advil and Motrin), U.S. health advisers ruled Tuesday.

The decision was highly anticipated, since a vote in favor of naproxen's superiority might have led to a product labeling change, experts said.

However, the 16-9 vote by the advisory panel to the U.S. Food and Drug Administration did not find enough evidence to put naproxen ahead of other pain relievers in terms of heart risk. The FDA isn't required to follow the recommendations of its advisory committees but it usually does so.

Naproxen, ibuprofen and aspirin fall under the umbrella term nonsteroidal anti-inflammatory drugs (NSAIDs). Millions of people take these medicines to help relieve muscle aches, headaches and pain from arthritis and injuries. These medicines also include the prescription drug Celebrex.

Since 2005, labeling laws have required a heart warning on these anti-inflammatory drugs. That warning stemmed from Merck's withdrawal of the NSAID Vioxx from the market in 2004 because of a notable increased risk of heart attack among Vioxx users.

An FDA panel concluded earlier this month that naproxen didn't seem to carry the same heart risks as the other NSAIDs. That decision was based on a safety review involving 350,000 people using different pain relievers.

But the FDA advisory committee decided Tuesday, after two days of hearings, that there wasn't enough evidence to state that naproxen was safer for the heart.

"If I were forced to bet on what the truth is, my bet would be that naproxen is somewhat safer," panelist Dr. Susan Ellenberg, of the University of Pennsylvania, told the Associated Press. "On the other hand, I'm not sure how that relates to our regulatory standard, as there's still a lot of uncertainty here."

But another panelist, Dr. Peter Kaboli of the University of Iowa, told the AP: "I'm convinced enough to change my own use of NSAIDs to naproxen, and that of my patients, based on what I've heard these last two days."

Aspirin wasn't a focus of this week's hearings.

More information

The American College of Rheumatology has more about pain relievers.
Copyright © 2014 HealthDay. All rights reserved.


SOURCES: Feb. 10, 2014, news release, U.S. Food and Drug Administration; Associated Press...

InteliHealth
.
.
.
.
.
More News
InteliHealth .
.
General Health News
Today's News
Today In Health History
This Week In Health
Addiction News
Allergy News
Alzheimer's News
Arthritis News
Asthma News
Babies News
Breast Cancer News
Bronchitis News
Cancer News
Cervical Cancer News
Children's Health News
Cholesterol News
Dental/Oral Health News
Depression News
Diabetes News
Ear, Nose And Throat News
Environmental Health News
Eye News
Fitness News
Genetics News
Headache News
Health Policy News
Heart Attack News
Heart Failure News
Heart Health News
HIV/AIDS News
Infectious Diseases News
Influenza News
Lung Cancer News
Medication News
Men's Health News
Mental Health News
Multiple Sclerosis News
Nutrition News
Parkinson's News
Pregnancy News
Prostate Cancer News
Schizophrenia
Senior Health News
Sexual/Reproductive Health News
Sexual dysfunction
Sleep News
STDs News
Stroke News
Tobacco Cessation News
Weight Management News
Women's Health News
.
.
.
.
InteliHealth
    Print Printer-friendly format    
   
.  
This website is certified by Health On the Net Foundation. Click to verify.
.