Navigation Links
FDA Puts Partial Hold on Avandia Safety Study
Date:7/21/2010

WEDNESDAY, July 21 (HealthDay News) -- No new patients will be permitted to enroll in a safety study of the controversial diabetes drug Avandia until further notice, the U.S. Food and Drug Administration announced Wednesday.

But under the partial clinical trial hold, those patients already enrolled in the TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) trial will be allowed to continue to participate, the agency said in a news release.

An FDA advisory panel last week ruled that Avandia (rosiglitazone) does boost users' heart risks, but it also decided that the drug should stay on the market because there's no definitive evidence of an increased risk.

The FDA said Wednesday that it is evaluating available data on Avandia's safety and the discussions from last week's advisory panel meeting. When the review is complete, the agency will inform the public about the findings and what they mean for the drug's status and the TIDE trial.

GlaxoSmithKline, which makes Avandia, was told by the FDA to update researchers, institutional review boards and ethics committees involved in the TIDE trial about new safety information presented at the FDA advisory panel meeting. That information can be used to update informed consent information for people already enrolled in the TIDE trial, the FDA said.

GSK agreed to conduct the TIDE trial in 2007 after concerns about the safety of Avandia first became public. The goal of the trial is to determine whether Avandia poses greater heart risks than a competing drug called Actos.

In a news release, the drug company confirmed that it will suspend enrollment of new patients in the TIDE trial and send a summary of recent safety data and a summary of the FDA advisory panel meeting to all TIDE researchers and institutional review boards.

"This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FD
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2

Related medicine news :

1. Lacosamide validated as promising therapy for uncontrolled partial-onset seizures
2. Deep brain stimulation reduces epileptic seizures in patients with refractory partial and secondarily generalized seizures
3. Study shows partial lung removal favorable over full removal as treatment for lung cancer
4. Hip surgery success partially predicted by number of other existing conditions
5. Diabetes Drugs Avandia, Actos Tied to Fractures in Women
6. Remove Diabetes Drug Avandia From Market: FDA Reports
7. Remove Diabetes Drug Avandia From Market: FDA Documents
8. FDA Says It Hasnt Decided Whether to Pull Diabetes Drug Avandia Off the Market
9. FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the Market
10. Maher Law Firm Warns Avandia Users - NY Times Reports - FDA Recommends Recall of Avandia
11. Diabetes Drug Avandia Ups Heart Risk, Reviews Conclude
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Puts Partial Hold on Avandia Safety Study
(Date:7/25/2014)... 25, 2014 Reproductive Science Center (RSC) ... Dr. Kerri Luzzo, Lead Physician at RSC Rhode Island, ... professional accomplishments in fertility care and community outreach issued ... 10th Annual PBN Awards ceremony held July 24th at ... the most highly regarded, emerging leaders in their field ...
(Date:7/25/2014)... The Little Gym of Houston will ... July 27 at Discovery Green in downtown Houston. The ... Pearland, Friendswood, Spring, The Woodlands, Sugarland-Missouri City, Kingwood, Bellaire ... “We’re thrilled to be attending and performing at the ... owns the Sugarland-Missouri City location. “We believe in the ...
(Date:7/25/2014)... AttorneyOne.com, a recognized authority on law, update the ... on Ibuprofen and Oxcarbazepine Tablets . , The ... and one lot of Oxcarbazepine Tablets, by American Health Packaging ... is used for the treatment of certain types of seizures ... the recall is that Lot #142588, Expiration Date, 01/2016 of ...
(Date:7/25/2014)... (PRWEB) July 25, 2014 Ticket Down ... vs. Inter Milan tickets in Berkeley at California Memorial ... many new fans of football, the organizers of the 2014 ... best club teams to North America. With teams representing La ... tournament will bring some of the best football players from ...
(Date:7/25/2014)... On July 22, 2014, ... and the nation’s number one provider of legally-compliant, ... their partnership with TransAct Merchant Solutions’ National Association ... of Chase Paymentech Solutions, LLC, which provides sales ... that are members of TransAct’s National Association Program ...
Breaking Medicine News(10 mins):Health News:Dr. Kerri Luzzo of the Reproductive Science Center of Providence Receives “40 Under Forty Award" for Outstanding Professional Accomplishments and Community Outreach 2Health News:The Little Gym of Houston to Attend Houston Family Magazine’s Family Fun Fest 2014 2Health News:Ibuprofen and Oxcarbazepine Tablets Recalled: AttorneyOne Monitors and Keep Consumers Informed 2Health News:Real Madrid vs. Inter Milan Tickets Berkeley: Ticket Down Slashes Ticket Prices on Guinness International Champions Cup Tickets at California Memorial Stadium 2Health News:Real Madrid vs. Inter Milan Tickets Berkeley: Ticket Down Slashes Ticket Prices on Guinness International Champions Cup Tickets at California Memorial Stadium 3Health News:Nuanced Media Client, CEDR HR Solutions, Partners with TransAct to Serve Medical, Dental, and Eye Care Professionals 2
... March 3 The United States,Conference of Catholic ... February 27 approval of a new, bipartisan bill ... expected in March., Bishop Thomas G. Wenski ... International Justice and Peace, and Cardinal Justin Rigali ...
... Patient Access to ... ... Talecris Biotherapeutics, Inc. have donated $150,000 to Lucile,Packard Children,s Hospital at Stanford ... two,organizations announced today., PI is a term that encompasses more than ...
... a new tool designed to measure a womans willingness to ... transmission of HIV), researchers at The Miriam Hospital and Brown ... the past, and those with casual sexual partners were more ... , Although a safe and effective microbicide has not been ...
... Identifying Core Components of Spine Care Centers ... ... SpineMark Corporation,and NeuStrategy, Inc. have joined forces to conduct the ... provide an accounting of spine centers across the nation and uncover,spine ...
... release is available in German . ... of two phases: deep, dreamless slow-wave-sleep (SWS) alternates with ... studies suggest that information is processed and memories are ... in neurobiology. Comparative studies in birds may help to ...
... problems more likely in the overweight , , MONDAY, March ... likely than normal-weight children to have breathing-related problems during ... , The researchers, who looked at 1,380 normal-weight, 351 ... who had elective, non-cardiac surgery, found that obese children ...
Cached Medicine News:Health News:Catholic Bishops Welcome New Bill for Global HIV/AIDS Relief 2Health News:Jeffrey Modell Foundation and Talecris Biotherapeutics Expand Diagnostic Services for Primary Immunodeficiencies at Lucile Packard Children's Hospital at Stanford 2Health News:Jeffrey Modell Foundation and Talecris Biotherapeutics Expand Diagnostic Services for Primary Immunodeficiencies at Lucile Packard Children's Hospital at Stanford 3Health News:Jeffrey Modell Foundation and Talecris Biotherapeutics Expand Diagnostic Services for Primary Immunodeficiencies at Lucile Packard Children's Hospital at Stanford 4Health News:Researchers develop new tool to predict who will use microbicides 2Health News:Researchers develop new tool to predict who will use microbicides 3Health News:SpineMark, NeuStrategy Partner to Conduct Nation's First Spine COE Survey(TM) 2Health News:SpineMark, NeuStrategy Partner to Conduct Nation's First Spine COE Survey(TM) 3Health News:'Power napping' in pigeons 2Health News:Obese Children Face More Complications During Surgery 2
(Date:7/24/2014)... July 24, 2014  Uroplasty, Inc. (NASDAQ: ... manufactures and markets innovative proprietary products to treat ... fiscal 2015 first quarter ended June 30, 2014.  ...  PC Neuromodulation System grew 19% to $4.1 million, ... quarter of the prior year.  Total revenue for ...
(Date:7/24/2014)... VIEW, Calif. , July 24, 2014  IRIDEX ... it will release its second quarter 2014 financial results ... 2014. In conjunction with the release, the Company ... at 5:00 p.m. Eastern Time on ... of the quarter and other business developments. ...
(Date:7/24/2014)... 24, 2014 IGI Laboratories, Inc. (NYSE MKT: ... specialty generic pharmaceutical company, today announced it has accepted  ... Directors.  Mr. Finio has accepted a senior level finance ... of his acceptance of his new position, Mr. Finio ... Director for IGI Laboratories, Inc.  The effective date of ...
Breaking Medicine Technology:Uroplasty Reports Fiscal First Quarter Results 2Uroplasty Reports Fiscal First Quarter Results 3Uroplasty Reports Fiscal First Quarter Results 4Uroplasty Reports Fiscal First Quarter Results 5Uroplasty Reports Fiscal First Quarter Results 6Uroplasty Reports Fiscal First Quarter Results 7Uroplasty Reports Fiscal First Quarter Results 8Uroplasty Reports Fiscal First Quarter Results 9Uroplasty Reports Fiscal First Quarter Results 10Uroplasty Reports Fiscal First Quarter Results 11IGI Laboratories, Inc. Announces Change To Its Board Of Directors 2
... DIEGO, Jan. 10, 2011 Optimer Pharmaceuticals, Inc. (Nasdaq: ... Linda Amper, Ph.D., as Senior Vice President of Human ... Economics & Outcomes Research (HEOR), and John Womelsdorf, Ph.D., ... will strengthen the management team as the Company prepares ...
... Calif., Jan. 10, 2011 OncoMed Pharmaceuticals, Inc., ... today announced that patient dosing has commenced in a Phase ... tumor cancers.   OMP-59R5 is a monoclonal antibody ... to specifically block these targets to enter human studies.  The ...
Cached Medicine Technology:Optimer Pharmaceuticals Announces Key Additions to Management Team 2Optimer Pharmaceuticals Announces Key Additions to Management Team 3Optimer Pharmaceuticals Announces Key Additions to Management Team 4OncoMed Pharmaceuticals Initiates Phase 1 Clinical Trial of Anti-Cancer Stem Cell Therapeutic OMP-59R5 2OncoMed Pharmaceuticals Initiates Phase 1 Clinical Trial of Anti-Cancer Stem Cell Therapeutic OMP-59R5 3
Its generous filter placement, MicroPoint design, and reference marks at 10, 50, and 100 ul make this ART tip ideal for many 200 ul pipettors....
With graduation marks at 10, 50, and 100 L and MicroPoint design, it is easy to ensure accurate sample handling on single and multichannel pipettors....
Ambion's barrier tips prevent cross-contamination of samples by means of an aerosol filter. They are RNase- and DNase-free and are ideal for handling RNA, PCR applications, and for working with radio...
10 L, Bulk Recommended for 2, 5 and 10 L pipettes....
Medicine Products: