Navigation Links
FDA Reviewer Questions Results of Key Avandia Trial
Date:7/11/2010

study was conducted according to good clinical practices and the data are reliable. . . RECORD demonstrated that Avandia was not associated with an overall increase in cardiovascular hospitalization or cardiovascular death compared to metformin and sulfonylureas."

But Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, said Friday, "If the data from RECORD had truly been mishandled in some way, not only is it going to pretty well be the end of Avandia in the clinical world, but it's going to put GlaxoSmithKline under the magnifying glass in an important way for clinicians going forward. They'll lose credibility, and that's tough to get back."

"There is an alternative drug out there," Garratt added. "From the clinical side, it's a fortunate circumstance that we find ourselves in, since we have an alternative product that seems to have [little] risk associated with it."

Actos (pioglitazone), made by Takeda, is in the same pharmaceutical class as Avandia. Both are medications known as thiazolidinediones (TZDs), which are blood-sugar-lowering drugs. Both are used by type 2 diabetics.

"The bulk of studies have suggested that Avandia is associated with greater cardiovascular mortality than the alternative, which is pioglitazone," noted Dr. Ronald Goldberg, a professor of medicine at the University of Miami Miller School of Medicine, on Friday.

This is only the latest in a series of conflicting information about Avandia's heart risks. In November of 2007, the FDA added a boxed warning to the drug, saying that there was a potential risk of increased cardiovascular ischemic events. Patients also began receiving a medication guide explaining the risks.

But just last week, three studies emerged with conflicting conclusions about the drug's safety. Two of them, published in major medical journals, found that Avandia did raise heart risks, while the third, released at th
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3 4

Related medicine news :

1. Readers and Reviewers Rave about 'The Skinny On Willpower'
2. Few High-Quality Studies on Food Allergies, Say Reviewers
3. Study Questions Value of Test for Peripheral Artery Disease
4. BestFoodFacts.org -- Food, Fiber and Fuel Questions Answered
5. National Event Addresses Breakthroughs in Crohn's & Colitis Research: National Expert & Researcher Answers Key Questions on Interactive Webcast/Teleconference
6. New study questions benefits of elective removal of ovaries during hysterectomy
7. Panel questions VBAC bans, advocates expanded delivery options for women
8. New Master Cleanse Website Offers Open Q&A For Master Cleanse Diet Questions
9. New iVillage Study Reveals That Majority of Women 18-34 Go Online First With Health Questions - Before Turning to Their Doctor or Other Family Members
10. Live Online Chats Answer Questions About Vascular Disease
11. Study Questions Use of Heart Device Implants in the Very Old
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Reviewer Questions Results of Key Avandia Trial
(Date:10/1/2014)... strongly associated with Alzheimer,s disease; however, researchers are still ... causal agent of the onset and development of the ... beta-amyloid is not harmful when found in isolation but ... to form the so-called amyloid fibrils , "We are ... with multiple ones because each aggregate of peptide, which ...
(Date:10/1/2014)... published today in the Journal of the American ... 50 years with moderate or severe chronic knee pain, ... the University of Melbourne randomly assigned 282 patients (50 ... acupuncture or sham or pretend laser treatment. , ... acupuncturists blinded to laser and sham (inactive) laser acupuncture. ...
(Date:10/1/2014)... Physical Sciences Research Council (EPSRC) will focus on ... systems which run, for example, manufacturing plants, power ... , The research will help understand and ... systems behind our critical national infrastructure. , ... (RITICS), based at Imperial College London, is co-ordinating ...
(Date:10/1/2014)... 2014) Despite a policy focus on expanding ... this vulnerable population continues to have significant dental ... Journal of the American Dental Association , researchers ... University School of Dental Medicine report on the ... oral care provided by caregivers to adults with ...
(Date:10/1/2014)... October 01, 2014 Familylifeinsurancequotes.org has ... life insurance for senior citizens. , Senior citizens ... will now sell coverage to seniors who are over ... be purchased without taking a medical examination. , Term ... online and senior clients can qualify. Having life insurance ...
Breaking Medicine News(10 mins):Health News:Laying siege to beta-amyloid, the key protein in Alzheimer's disease 2Health News:Study finds acupuncture does not improve chronic knee pain 2Health News:£2.5 million to recognize and reduce cyber-attack threats to critical infrastructure 2Health News:To improve oral health of adults with developmental disabilities, support caregivers 2Health News:To improve oral health of adults with developmental disabilities, support caregivers 3Health News:Affordable Term Life Insurance - Senior Citizens Can Qualify for Coverage! 2
... LLC, a leading provider,of real-time software products and ... Duluth, Minn.-based ALLETE, Inc, has selected InStep,s,eDNA historian ... health monitoring and analysis needs. , ... with several critical power delivery,systems and applications including ...
... 30 million drivers in the US aged 65 and over, ... no longer drive safely and decide that it,s time to ... decrease in vision function is a key factor in bringing ... Study (SEEDS) ( http://www.iovs.org/cgi/content/full/50/1/107 ), conducted by researchers affiliated with ...
... Web-Based Community for Parents of Children with DisabilitiesNEWTON, ... community for parents of disabled children, today announced ... to assist parents of children with disabilities, the ... resource library for families. ChildRC ( www.ChildRC.com ) ...
... middle age, study says , , TUESDAY, Jan. 6 (HealthDay News) ... painfully obvious, nutrition experts have been divided over whether cutting ... sometimes boomerang, triggering binge eating and weight gain. , But, ... particularly as you age. , Publishing in the current issue ...
... Two children have a seizure. One child never has another ... of seizures and is diagnosed with epilepsy. A study being ... what could possibly happen in the development of these two ... neurologic health. , The findings reveal that genetic predisposition, ...
... KENILWORTH, N.J., Jan. 6 Schering-Plough Corporation (NYSE: ... results for the 2008 fourth quarter and full year on ... that day, Schering-Plough will conduct a conference call to review ... Fred Hassan, Schering-Plough,s chairman and CEO, and other members of ...
Cached Medicine News:Health News:Minnesota Power Selects InStep's eDNA Historian Software for Enterprise Operational and Asset Health Related Data Management 2Health News:Vision problems prompt older drivers to put down the keys 2Health News:ChildRC.com Launches The Child Resource Center 2Health News:It Pays to Eat Less as You Age 2Health News:Study yields clues about the evolution of epilepsy 2Health News:Study yields clues about the evolution of epilepsy 3Health News:Schering-Plough Schedules Conference Call and Webcast for 2008 Fourth Quarter and Full Year Earnings 2
(Date:10/1/2014)... 2014 NeuroCall, Inc., ("NeuroCall") announced today that ... and Teleneurology services. Dr. Ricardo Garcia-Rivera , Founder ... extremely proud that our quality of service has been ... provide lifesaving support and continuity of care to patients ... the United States ." ...
(Date:10/1/2014)... Oct. 1, 2014   Cypher Genomics, Inc., ... J. Patrick Ravenel as chief technology officer. ... and systems experience and a proven track record of ... "Patrick has been recognized as a top ... and is known industry-wide for delivering innovative products that ...
(Date:10/1/2014)... , Oct. 1, 2014   Royal Philips ... today announced its eCareCoordinator and eCareCompanion telehealth applications ... and Drug Administration (FDA). A part of Philips ... , eCareCoordinator and eCareCompanion are focused on patient ... clinical applications to be available through the cloud-based ...
Breaking Medicine Technology:NeuroCall Awarded Joint Commission Accreditation 2Cypher Genomics Appoints J. Patrick Ravenel Chief Technology Officer 2Philips Secures 510(k) Clearance to Market the First Clinical Applications for its new Digital Health Platform 2Philips Secures 510(k) Clearance to Market the First Clinical Applications for its new Digital Health Platform 3Philips Secures 510(k) Clearance to Market the First Clinical Applications for its new Digital Health Platform 4
... May 15, 2012  Coloplast North America, a provider of ... has announced a corporate sponsorship of Michael Johnson, formula ... competing this year in The Cooper Tires USF2000 Championship ... to Indy, an open-wheeled development program for drivers seeking ...
... 2012 Medical Marijuana, Inc . (OTC: MJNA), ... and hemp industry innovators, today announced its first quarter ... million on gross revenues of $1.79 million for the ... revenue increase of 400 plus percent quarter-over-quarter when compared ...
Cached Medicine Technology:First Paralyzed Formula Race Car Driver's "Road to Indy" Sponsored By Coloplast 2Medical Marijuana, Inc. Announces First Quarter 2012 Results 2Medical Marijuana, Inc. Announces First Quarter 2012 Results 3Medical Marijuana, Inc. Announces First Quarter 2012 Results 4Medical Marijuana, Inc. Announces First Quarter 2012 Results 5
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: