Navigation Links
Remove Diabetes Drug Avandia From Market: FDA Documents
Date:2/20/2010

tific evidence and a recommendation by an independent advisory committee of experts convened by the FDA, the agency has ruled that Avandia remain available to patients for the treatment of Type 2 diabetes."

In the wake of the controversy, the drug company had been directed by the FDA to conduct a trial comparing rates of heart attacks, strokes and heart-linked deaths among users of Avandia, Actos or a placebo. But according to internal documents accessed by the Times, Graham and Gelperin characterized the study, called TIDE, as "unethical and exploitive," with patients being given Avandia despite the fact that it appears to come with greater risks and no added benefit over Actos.

One of the Graham/Gelperin reports -- dated October 2008 -- concludes that, "Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable."

However, other FDA officials overruled those concerns and TIDE is still enrolling patients, with preliminary results expected by 2014. Responding to the criticism, GlaxoSmithKline noted Saturday that, "TIDE has been approved by an independent review board and appropriate safety boards that are responsible for assessing the safety of conducting the trial."

The ongoing controversy has dampened patients' and physicians' enthusiasm for Avandia. According to the Times, while sales of the drug topped $3.2 billion in 2006, those numbers plummeted soon after the first studies suggesting risk emerged a year later.

Still, "hundreds of thousands" of people still take Avandia, the Times noted. GlaxoSmithKline's patent on the drug expires in 2012.

More information

Find out more about diabetes care at the American Diabetes Association.




'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. Single-incision belly-button surgery to remove kidney performed first at UT Southwestern
2. Surgeons Remove Gallbladder Through Vagina
3. CVS/pharmacy to Remove OTC Infant Cough & Cold Products from Its Stores as Part of CHPAs Voluntary Withdrawal
4. Prominent Farmington Plastic Surgeon Uses Two New Non-Surgical Procedures to Tighten Skin and Remove Fat
5. Stop & Shop Removes Childrens Cough and Cold Medicine from Store Shelves
6. Giant Food Removes Childrens Cough and Cold Medicine From Store Shelves
7. Schwarzenegger Signs Bill to Remove Written Informed Consent for HIV Testing; "Most Important Change in Public HIV/AIDS Policy in Years," Says AHF
8. Health Groups Call on Cosmetic Giant LOreal to Remove Lead From Lipstick
9. Video: Trinity Mother Frances Neurosurgeon First in Region to Remove Brain Tumor Using Unique Surgical Procedure
10. Nations Largest Pet Insurer Reveals Top 10 Items Surgically Removed From Pets
11. Safety Concerns Prompt Prime to Remove Avandia(R) from Formulary
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/25/2014)... December 26, 2014 The ... combines beauty, strength and durability. Today, the business ... which is valid until Jan. 30, 2015. , ... of traditional hardwood. BambooFlooringChina.com is a well-known brand ... consumers worldwide to find a reliable bamboo flooring ...
(Date:12/25/2014)... iFitDress.com, the popular online supplier of wedding dresses and special ... black one-shoulder cocktail dresses . In addition, all these ... discounted prices, up to 70% off. , The ... only. You know, we have thousands of frequent callers in ... items can visit our website for more details. The current ...
(Date:12/25/2014)... 25, 2014 Helen Harris’ RP (Retinitis ... Hills, California after an 8 year battle with breast ... Eve evening in her home in Woodland Hills California ... cancer. , As the founder and ... she pioneered and championed many of today's greatest breakthroughs ...
(Date:12/25/2014)... 25, 2014 (HealthDay News) -- Overeating is common during the ... in moderation, an expert says. "Don,t arrive at a ... if you know you,ll be attending a party, but deprivation ... lead dietitian at Northern Westchester Hospital in Mount Kisco, N.Y., ... eat healthy during the day and even to have a ...
(Date:12/25/2014)... December 25, 2014 “ SmileStix ” was ... features the latest and coolest mobile applications on the iOS, ... and host of NewsWatch, conducted the app review and shared ... create personal stickers. , The old saying goes, “A picture ... of words that can describe a single image, because each ...
Breaking Medicine News(10 mins):Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:iFitDress.com: Black One-Shoulder Cocktail Dresses for 2015 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 3Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 4Health News:An Application to Create Custom Stickers was Featured on NewsWatch Television on December 19, 2014 2
... for bowel cancer at Queen,s University Belfast has received ... Dr Sandra Van Schaeybroeck, whose research aims to identify ... a prestigious 688,000 Cancer Research UK Clinical Scientist Fellowship. ... four fellowships awarded to UK clinical investigators, renews Dr ...
... ,Surgeons aged 35 to 50 provide the safest care for ... about ongoing training and motivation of surgeons during their careers, ... France. They analyzed data from 3,574 thyroidectomies (removal of ... over a one-year period. The average age of the surgeons ...
... , TUESDAY, Jan. 10 (HealthDay News) -- Children with autism ... bacteria seen in kids who do not have the disorder, ... 10 in the online journal mBio , researchers from ... New York City suggested that this finding could help explain ...
... patients improved between 2003 and 2008, according to a ... Outcomes , an American Heart Association journal. The study ... of care, and that differences in care between the ... because little is known about the treatment and outcomes ...
... By Serena Gordon HealthDay Reporter , TUESDAY, Jan. ... new research suggests those costs may extend far beyond the ... study authors found that young people with diabetes were more ... lifetime, could expect to earn about $160,000 less than those ...
... that older Americans with cirrhosis have significantly worse health ... this potentially deadly disease. In fact, findings now published ... American Association for the Study of Liver Diseases, show ... of informal caregiving and contribute added strain on the ...
Cached Medicine News:Health News:Groundbreaking cancer research receives massive funding boost 2Health News:Surgeons in Mid-Career Have Fewest Complications: Study 2Health News:Autism Gastro Problems May Be Linked to Gut Bacteria 2Health News:Asian-Americans getting better heart attack care 2Health News:Diabetes Takes a Toll on Lifetime Earnings: Study 2Health News:Diabetes Takes a Toll on Lifetime Earnings: Study 3Health News:Diabetes Takes a Toll on Lifetime Earnings: Study 4Health News:High rates of disability and health care use for older americans with cirrhosis 2
(Date:12/24/2014)... TIJUANA, Mexico , Dec. 24, 2014 /PRNewswire/ ... treatment of its first patient in its study ... to the American Stroke Association, ischemic strokes account ... continues to enroll qualified patients in the study, ... Intravenous Administration of Allogeneic Mesenchymal Stem Cells and ...
(Date:12/24/2014)... PRINCETON, N.J. , Dec. 24, 2014 /PRNewswire/ ... Company), a late-stage biopharmaceutical company developing products that ... inflammation, oncology and biodefense, announced today that on ... registered public offering. The Company raised ... offering and intends to use the net proceeds ...
(Date:12/24/2014)... and LONDON , December 24, ... industry are expected to grow at an average rate ... of value and volume. Hip, knee and spine surgeries ... while in emerging economies they have a lower penetration. ... challenging the use of composites. Non-metallic orthopedic devices have ...
Breaking Medicine Technology:Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 2Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 3Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 4Soligenix Announces Closing of Public Offering of Units 2Soligenix Announces Closing of Public Offering of Units 3Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 3
... Pharmaceuticals, Inc. (NYSE: WPI ) today ... Watson Laboratories, Inc. -- Florida, (collectively "Watson") filed ... Food and Drug Administration (FDA) seeking approval to ... 20, 30, 40, 60 and 80 mg strengths. ...
... Science (Tianjin) Co. Ltd, a leading research-based contract manufacturer of ... in the U.S. and China, is pleased to announce the ... Quality Assurance as of March 1, 2011. ... in the pharmaceutical industry (early and late stage), in quality ...
Cached Medicine Technology:Watson Confirms OxyContin® Patent Challenge 2Watson Confirms OxyContin® Patent Challenge 3Mr. Robert Andrews Joins Asymchem Life Science (Tianjin) Co. Ltd. as Vice President of Quality Assurance 2
... Complete procedure information to facilitate diagnostic ... monitor is a sterile, disposable device used ... nucleus during discography procedures. The device will ... display it in a digital format. The ...
Smith & Nephew's CDS System is developed exclusively for discography., Developed exclusively for discography, it is the first system designed to measure true disc pressure and record real-time proce...
The ACCU-DISC™ pressure monitoring system offers the advantage of accurate delivery of fluids to the body with the ability to monitor the pressure of those fluids in discography interpretation....
The °CureWrap is one-piece garment offers maximum available surface coverage, while avoiding the sterilized fields of operation....
Medicine Products: