Navigation Links
GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition
Date:10/30/2008

PHILADELPHIA, Oct. 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today issued the following response to a petition filed by Public Citizen to the U.S. Food and Drug Administration (FDA) on AVANDIA(R) (rosiglitazone maleate), a highly effective therapy for treating type 2 diabetes when used in the appropriate patient population.

The safety of patients using our medicine is very important to us. On a continual basis, an external Hepatic Safety Board reviews any adverse event report received by GSK of liver failure, liver-related deaths and liver transplants for possible relationship to AVANDIA. As recently as July 2008, this panel of experts continued to endorse a favorable hepatic safety profile for AVANDIA.

Patients being treated with AVANDIA or other medicines to control blood sugar levels should remain on therapy, unless their doctor advises a different course of action.

AVANDIA has been shown to be a safe and highly effective treatment for type 2 diabetes for the appropriate patient. GSK strongly supports the safety and efficacy of AVANDIA based on extensive clinical trial experience and widespread post-marketing use. The record of safety and effectiveness of AVANDIA is backed by one of the largest clinical trial programs (including 52,000 patients) ever undertaken for any medicine.

Data from long-term clinical trials, which offer the most rigorous scientific measurement of safety and efficacy, provide substantial evidence to assess the benefit-risk of AVANDIA in treating patients with diabetes. Importantly, the Public Citizen petition did not include data from the current Prescribing Information for AVANDIA regarding ADOPT (A Diabetes Outcomes Progression Trial). ADOPT, the largest head-to-head diabetes trial, showed that AVANDIA sustained glycemic control longer than metformin or sulfonylurea, for up to five years. Additionally, outcomes from five long-term clinical studies did not demonstrate an increased risk of t
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Concludes There is No Increased Risk of Cardiac Events for Patients Treated with omeprazole and NEXIUM(R) (esomeprazole magnesium)
2. Jennerex Completes the Treatment of First Patient Cohort in Phase 1 Trial With Intravenous Delivery of JX-594 Oncolytic Virus
3. Experts Assert That Varian Technologies Deliver Speed and Clinical Accuracy in Treating Cancer Patients
4. CEL-SCI Expects to Take Delivery of New Manufacturing Facility on October 8, 2008
5. Oramed Pharmaceuticals Launches GLP1-Analog Program, Based on its Proprietary Drug Delivery Platform
6. New Data Support Earlier Suggested Guidance for Levels of Cell-Mediated Immunity in Pediatric Liver Transplant Patients
7. Bayer and Onyx Begin Enrollment in STORM Trial Studying Nexavar as Adjuvant Therapy for Patients With Liver Cancer
8. The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer
9. Jennerex Publishes Clinical Trial Data With Lead Product JX-594 Demonstrating Efficacy Against Liver Cancer and Associated Hepatitis B Virus
10. Raptor Pharmaceuticals Enters Collaboration Agreement with UC San Diego in Liver Disease
11. (RED) to Launch New Way for People to Get Music in Their Lives; Weekly Delivery of Great Music Helps to Save Lives in Africa
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... -- Strategic Health Services, Inc. (SHS), a leading provider of ... agreement with QualCare, Inc., a leading provider of health plans ... marketplace.  This agreement will further QualCare,s population health management ... brings to its clients in New Jersey ... QualCare plans cover more than 800,000 member lives, with ...
(Date:12/17/2014)... December 17, 2014 , ... than a hub of information concerning the biopharmaceutical Group,s national ... A further addition to the recently launched institutional website that ... now been enriched by a new chapter in the fascinating ... A richly detailed and panoramic hub on the world of ...
(Date:12/17/2014)... Ga. and RALEIGH, N.C. ... Trial Marketing Communications, LLC (CTMC), and Integrated Clinical ... patient recruitment and retention for clinical trials announce ... Integrated Clinical Trial Marketing Services (i-CTMS). i-CTMS will ... retention services to pharmaceutical, biotechnology and medical device ...
Breaking Medicine Technology:Strategic Health Services to collaborate with QualCare on Population Health and Wellness Technology for QualCare Members 2Strategic Health Services to collaborate with QualCare on Population Health and Wellness Technology for QualCare Members 3Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 2Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 3Integrated Clinical Trial Services and Clinical Trial Marketing Communications Form Joint Venture 2Integrated Clinical Trial Services and Clinical Trial Marketing Communications Form Joint Venture 3
... France and SWIFTWATER, Pa., June 16 Sanofi,Pasteur, the ... donate 60 million doses of H5N1 vaccine to the ... of an H5N1 vaccine,global stockpile., "The H5N1 virus ... the world and an outbreak of pandemic influenza would ...
... Results presented at the 90th annual Endocrine Society meeting show,significant ... ... painful intercourse, ANN ARBOR, Mich, June 16 QuatRx ... 3 clinical,trial of Ophena(TM) (ospemifene tablets) to treat postmenopausal women ...
Cached Medicine Technology:Sanofi Pasteur to Donate 60 Million Doses of H5N1 Vaccine to WHO Over 3 Years for its Influenza Vaccine Global Stockpile 2Sanofi Pasteur to Donate 60 Million Doses of H5N1 Vaccine to WHO Over 3 Years for its Influenza Vaccine Global Stockpile 3Sanofi Pasteur to Donate 60 Million Doses of H5N1 Vaccine to WHO Over 3 Years for its Influenza Vaccine Global Stockpile 4Sanofi Pasteur to Donate 60 Million Doses of H5N1 Vaccine to WHO Over 3 Years for its Influenza Vaccine Global Stockpile 5Quatrx Pharmaceuticals Presents Results From Ophena(TM) (Ospemifene Tablets) Phase 3 Study Related to Treatment of Symptoms of Vulvovaginal Atrophy 2Quatrx Pharmaceuticals Presents Results From Ophena(TM) (Ospemifene Tablets) Phase 3 Study Related to Treatment of Symptoms of Vulvovaginal Atrophy 3Quatrx Pharmaceuticals Presents Results From Ophena(TM) (Ospemifene Tablets) Phase 3 Study Related to Treatment of Symptoms of Vulvovaginal Atrophy 4
(Date:12/19/2014)... 2014 Today, Balfleet.com , a ... announces its formal dress promotion. All the old and ... 60% off. , Balfleet.com is well-known for its high ... prom dresses, cocktail dresses and more. Its formal dresses ... guarantee, and they can create an elegant look when ...
(Date:12/19/2014)... 19, 2014 Energy Textiles is ... now available. Celliant, the world’s leading responsive textile, ... pillowcases. , There are a number of benefits ... increased oxygenation and balanced body temperature; which can ... pain relief; enhanced athletic performance; and overall wellness. ...
(Date:12/19/2014)... OK (PRWEB) December 19, 2014 Eufaula, ... home to Lake Eufaula, the state’s largest lake with ... lakeside town is home to a little more than ... 1:00 P.M. on Saturday, the 6th of December. , ... its way through downtown Eufaula on Main Street. ...
(Date:12/19/2014)... December 20, 2014 The print component ... and Business subscription of the Toronto Star, with a ... of 622,169. The digital component is distributed nationally through ... of top news sites and partner outlets. To explore ... . , The publication features an exclusive interview ...
(Date:12/19/2014)... 2014 (HealthDay News) -- Potentially illness-causing E. coli bacteria ... farmers markets, according to a new study. Researchers ... from 13 farmers markets in Los Angeles and Orange ... of almost 150 samples tested, 24 percent were positive ... according to the researchers. Both types of bacteria ...
Breaking Medicine News(10 mins):Health News:Balfleet.com Announces Its Formal Dress Promotion For 2015 2Health News:Energy Textiles Launches Celliant Revitalizing Bedsheets 2Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 2Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 3Health News:Mark DeMontis, Founder of Courage Canada, shares his passion for bringing hockey to those affected by blindness in Mediaplanet’s “Vision and Hearing” campaign 2Health News:E. Coli Germs Found on Farmers Market Herbs 2
... their opinion- Nature’s way is far superior to pre-planned caesarian ... of it being unnecessary. , According to their ... encountered by a woman who opts for a C-section, in ... higher than that of a woman undergoing natural delivery. ...
... Researchers at UT Southwestern Medical Center have found that ... ,"We have discovered that C-Reactive Protein (CRP) ... hypertension, it actually induces hypertension," said Dr. Wanpen Vongpatanasin, ... the study appearing in the February issue of Circulation. ...
... PhD, published the first results showing that a biological phenomenon ... Since then he has used RNAi gene therapy to effectively ... mice. ,With three human RNAi gene therapy trials ... in RSV pneumonia - the technique Kay pioneered may be ...
... By first probing the way primitive yeast make ... long-sought protein whose human// counterpart controls cholesterol production ... study by investigators at Johns Hopkins University School ... Lilly Co., was published in the February issue ...
... Diabetes case management that takes a patient’s specific ... and decrease the incidence of diabetes-related complications over ... ,"Better management results in reduced long-term complications, ... said lead researcher Todd Gilmer, Ph.D. ...
... Jumping on a garden trampoline is a fun form of ... for children and youths// than traffic, according to a new ... of concern "especially due to neck and head injuries" that ... northern Sweden told the Svenska Dagbladet newspaper. ,The ...
Cached Medicine News:Health News:C-Reactive Protein Induces Hypertension 2Health News:RNAi Shows Promise in Gene Therapy 2Health News:Primitive Yeast Yields Secrets Of Human Cholesterol And Drug Metabolism 2Health News:Culturally Specific Diabetes Management Helps Low-Income Patients 2
The Fujinon's R410 laparoscope is the first to bring a 410,000 pixel CCD to the end of the scope. Superior imaging and color replication, along with a unique lens washing capability make the R410 the...
The ACMI™ Operative Laparoscopy System is designed for single- and dual-incision CO2 laser procedures and is used with 45cm laparoscopic instruments....
The edge-to-edge clarity of the laparoscopes provides excellent image definition.Even small structures are easily recognized due to the optimal depth of focus. The outstanding optical quality provide...
Stryker bariatric laparoscopes set the standard in picture quality....
Medicine Products: