Navigation Links
FDA Weighs Fate of Qnexa for Weight Loss, Again
Date:2/21/2012

By Denise Mann
HealthDay Reporter

TUESDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug Administration plans to take a second look at the weight loss pill Qnexa on Wednesday, after initially rejecting it because of concerns about heart problems and possible birth defects.

While effective at reducing weight, the drug, manufactured by Vivus Inc., was denied approval in 2010 because of its potential side effects. An FDA advisory panel will now review two years of data; when advisers last voted on Qnexa, only one year's worth of follow-up data was available.

The drug combines the appetite suppressant phentermine and the anti-seizure/migraine drug topiramate. Phentermine was once widely prescribed as the "phen" part of the fen-phen weight loss drug. This combo was withdrawn from the market after its use was linked to high blood pressure in the lungs and heart valve disease. The problems were related to the "fen" or fenfluramine part of the combination, not the phentermine.

No new weight-loss drug has been approved in the United States in the past 13 years, according to published reports. As it stands, Xenical is the only FDA-approved drug specifically for long-term use -- up to a year -- for weight loss. Xenical is sold over-the-counter as Alli. However, other drugs may be used off label to promote weight loss.

Last April, a study funded by Vivus found that obese patients taking Qnexa lost an average 22 pounds over a year, while also lowering their blood pressure and cholesterol levels.

Dr. Louis Aronne, founder and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, is cautiously optimistic that Vivus did a good job responding to FDA safety concerns, and that the FDA will give the drug its nod of approval, with some caveats. Aronne was not involved in the trials but has been an adviser to Vivus and other companies developing weight loss medications.

"I am not as pessimistic as most people," he said.

Vivus has reported that Qnexa may increase the risk of cleft lip in babies of women who use the drug while pregnant. Aronne said the birth defect concern could be addressed through education on who should and should not use the new drug.

"We have learned our lessons with weight loss drugs," he said. "They need to be used in the right people under the right circumstances." The heart risks need to be weighed against reductions in heart disease risk factors that come with weight loss, he said.

Qnexa is not any riskier than bariatric surgery, according to Aronne. "The problem is that it can be distributed more widely," he said. He hopes for a compromise that allows the new compound to be prescribed, but not misused. "Once new medications are approved, local medical boards will need to enforce rules and make sure these medications are prescribed appropriately to the right candidates," he said. "We don't want to open up pill mills."

One thing is clear, he said: More options to treat obesity are needed. "For hypertension, there are 120 medications in nine categories," Aronne said. "We need new options and we need to get physicians thinking about obesity and obesity treatments."

Dr. Scott Kahan, an obesity expert at Johns Hopkins University in Baltimore and director of the National Center for Weight and Wellness in Washington, D.C., agreed. He is optimistic about the FDA's upcoming decision on Qnexa. "The weight loss effects are striking and approaching the amount of weight loss over two years that we get with bariatric surgery," he said. "This is really impressive."

More information

Learn more about weight loss medications at the U.S. National Institutes of Health.

SOURCES: Louis Aronne, M.D., founder and director, Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center, New York City; Scott Kahn, M.D., associate director, Johns Hopkins Weight Management Center, Baltimore, and director, National Center for Weight and Wellness, Washington, D.C.


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. New York and Connecticut Drug Rehab Center Mountainside Weighs In on Latest White House Budget
2. Will Redmond ONeal Fulfill His Mothers Wishes? Promises Addiction Guru Dr. David Sack Weighs In.
3. FDA Panel Weighs New Restrictions on Tanning Beds
4. Predicto Mobile Community Weighs in on Celebrity Weight Loss
5. FDA Panel Weighs OK of Female Viagra
6. FDA Weighs In as Sharing of Breast Milk Booms
7. FDA Weighs Pros, Cons of Home Genetic Testing
8. Study weighs risks and benefits of birthing facilities
9. Maximized Living Named as Exclusive Chiropractic Partner of USA Weightlifting
10. New and Delicious, Almond Butter Filled, Cookie Bites With 35.7% Protein to Help Manage Weight and Build Muscle
11. Repeated Weight-Loss Surgery Carries Added Risks
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Weighs Fate of Qnexa for Weight Loss, Again
(Date:1/20/2017)... FL (PRWEB) , ... January 20, 2017 , ... ... and wellness products to enhance people’s everyday lives, recently attended the January ECRM ... buyers. , ATP Science is known for its large range of supplements that ...
(Date:1/20/2017)... California (PRWEB) , ... January 20, 2017 , ... "TransFlare ... to use inside of Final Cut Pro X," said Christina Austin - CEO of ... the RED Dragon. Utilizing the Dragon Sensor,TransFlare 4K Mystique lens flare and light leak ...
(Date:1/20/2017)... ... January 20, 2017 , ... “The Angel”: a heartwarming and ... out for each of his children. “The Angel” is the creation of published author, ... New York City, and impassioned writer. , When asked of her new book, Marjorie ...
(Date:1/20/2017)... ... January 20, 2017 , ... ... Oscillating Positive Expiratory Pressure (OPEP) device, was featured in a study indicating superior ... MEd, RRT-ACCS, FAARC, “Analysis of Three Oscillating Positive Expiratory Pressure Devices During ...
(Date:1/20/2017)... ... January 20, 2017 , ... “Knowledge is God’s Lighthouse”: ... faith. “Knowledge is God’s Lighthouse” is the creation of published author, Gene Gaapf, a ... poetry collections. , “I have been writing since high school and have many ...
Breaking Medicine News(10 mins):
(Date:1/20/2017)... Stock-Callers.com today evaluates the following Drug Manufacturers equities: ... A/S (NYSE: NVO ), Sucampo Pharmaceuticals Inc. (NASDAQ: ... PTX ). These stocks belong to the Healthcare ... finishing near its session lows. As per a NASDAQ report, ... of health care companies in the S&P 500 also were ...
(Date:1/20/2017)... -- Wells Specialty Pharmacy announces the acquisitions and merger of ... Winter Park, Florida and Pharm-EZ Medical, LLC, ... been consolidated into the 3796 Howell Branch Road Facility. ... Chad Tomlinson , former Vice President of Operations, has ... Tomlinson is a Graduate of Florida State University and has ...
(Date:1/19/2017)... 2017 Germany Cataract Surgery ... new report, "Germany Cataract Surgery Devices Market Outlook to ... Surgery Devices market. The report provides value, in millions ... (USD) within market segements - Phacoemulsification Equipment and Ophthalmic ... shares and distribution shares data for each of these ...
Breaking Medicine Technology: