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:7/9/2014)... in policing injection drug users in Russia might ... , A study, conducted by researchers from Boston ... collaboration with St. Petersburg Pavlov State University, sought ... the health outcomes of a cohort of HIV-positive ... Those who were arrested by police were more ...
(Date:7/9/2014)... By looking at ... structure and function, personality, life experiences and genetics, researchers can ... binge drinking within the next two years. Impulsivity, hopelessness, sensation-seeking ... events and a family history of drug use contribute to ... child had had a single drink at age 14 was ...
(Date:7/9/2014)... the world have been linked to an emerging ... the National Institute for Mathematical and Biological Synthesis ... contribute. , In a series of mathematical ... hemorrhage of internal organs in frogs, could cause ... they are exposed to the virus every few ...
(Date:7/9/2014)... of Allergy and Infectious Diseases (NIAID), part of ... early-stage clinical trial of CRS3123, an investigational oral ... ( C. difficile ) infection. CRS3123 (previously known ... C. difficile growth while sparing normal intestinal bacteria. ... to 30 healthy men and women ages 18 ...
(Date:7/9/2014)... printing on prescription labels handed out by pharmacists ... in taking medication, according to new research by ... Institute for the Blind)., The study, published recently ... that labels on prescription medications dispensed by pharmacies ... legibility. , By simply following recommended guidelines for ...
Breaking Medicine News(10 mins):Health News:BU researchers relate arrests with HIV risk environment 2Health News:What drives a child to abuse alcohol? 2Health News:Study predicts ranavirus as potential new culprit in amphibian extinctions 2Health News:NIH launches Phase I clinical trial of novel drug to treat Clostridium difficile infection 2Health News:Most prescription labels fail to meet guidelines, risking dosage errors 2
... is widespread among U.S. adolescents and young adults ages 14 ... the University at Buffalos Research Institute on Addictions (RIA). ... the first national survey of its kind show problem gambling ... (for example, gambling more than you intended or stealing money ...
... Vascular Insights LLC announced,today that it has received ... (FDA) to market its ClariVein(TM) infusion catheter for,infusion ... ClariVein(TM) is a percutaneous, 2 2/3 Fr (0.035") ... that enhances fluid dispersion in the,treatment area., ...
... 6 Epitomics, Inc. announced,today that its Hangzhou ... and production of its novel line of rabbit ... standard for quality management and ultimately the finest ... Dr. Guo-Liang Yu,President and CEO of Epitomics, Inc., ...
... Care Management: Making a ... Difference Today and Tomorrow, HARRISBURG, ... Medical Officer, will deliver the clinical keynote,address on Wednesday afternoon, ... the World of Care Management. Dr. Petrulis will,present Care Management: ...
... at dilated veins seen with cirrohosis but aren,t sensitive ... New noninvasive methods to detect esophageal bleeding in people ... Italian and American researchers. , About 25 percent of ... are extremely dilated veins commonly seen with cirrhosis. Variceal ...
... bowel movement, serious complications can follow, experts note , , ... have identified a marker that might predict which pregnant ... is essentially a baby,s first bowel movement, excreted in ... It is considered a sign of fetal distress. A ...
Cached Medicine News:Health News:Estimated 750,000 problem gamblers among America's youth 2Health News:Estimated 750,000 problem gamblers among America's youth 3Health News:Epitomics receives ISO 9001 certification for the production of Rabbit Monoclonal Antibodies. 2Health News:KePRO's Chief Medical Officer to Deliver Clinical Keynote Address 2Health News:Noninvasive Procedures Show Promise for Esophageal Bleeding 2Health News:Doctors Discover Marker for Meconium Passage During Delivery 2
(Date:1/14/2014)...  Luminex Corporation (Nasdaq: LMNX ) today announced that ... 2013 on Monday, February 3, 2014. A press release announcing ... trading. (Logo: http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ) ... highlights and financial results for the fourth quarter and twelve ...
(Date:1/14/2014)... , Jan. 14, 2014 /PRNewswire-iReach/ -- Acumed,s new SLIC ... guide with accompanying instrumentation to place and insert the ... the soft tissue (e.g. ligament) repair or reconstruction as ... heals. (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) ...
(Date:1/14/2014)... VALHALLA, N.Y. , Jan. 14, 2014   Oligomerix, Inc. ... disease modifying therapeutics for Alzheimer,s disease (AD) and related ... headquarters to Valhalla, NY as ... additional laboratory space at New York Medical College. ...
Breaking Medicine Technology:Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3Oligomerix Relocates Corporate Headquarters and Secures Additional Laboratory Space from New York Medical College 2
... June 22, 2011 CardioFocus, Inc., developer of the ... atrial fibrillation (AF), announced today that its technology will ... upcoming European Heart Rhythm Association (EHRA) EUROPACE 2011 congress, ... EAS is a unique catheter ablation technology that incorporates ...
... SHENZHEN, China, June 22, 2011 /PRNewswire-Asia/ -- Winner Medical Group ... Company"), a leading manufacturer of medical dressings, medical disposables and ... today announced the Company,s management team will present at the ... to be held on June 27 and 28, 2011 at ...
Cached Medicine Technology:CardioFocus HeartLightâ„¢ Endoscopic Ablation System to be Featured at EHRA EUROPACE 2011 2CardioFocus HeartLightâ„¢ Endoscopic Ablation System to be Featured at EHRA EUROPACE 2011 3Winner Medical to Present at Brean Murray, Carret & Co. Beijing China Growth Conference 2Winner Medical to Present at Brean Murray, Carret & Co. Beijing China Growth Conference 3
... PS+ lead series are endocardial ... the best characteristics of polyurethane ... polyurethane outer insulation provides a ... lubricity while the silicone inner ...
The Vitatron Slimtine S lead series are endocardial leads with an excellent history of reliability and optimal handling en pacing performance....
Unipolar Atrial "J" Lead...
VascoTip is a unipolar tined permanent pacing lead. Due to advanced technology, VascoTip 9/60 M is compatible to all pacemaker-cavities with the size of IS-1 (3.2 mm), 5 mm, 6 mm....
Medicine Products: