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 FDA Advisory Committee and the Committee's recommendations," Dr. Ellen Strahlman, GSK's chief medical officer, said in the news release.

"Patients with questions about the use of Avandia should talk with their physicians," she added.

More information

The U.S. National Library of Medicine has more about rosiglitazone.

-- Robert Preidt

SOURCES: U.S. Food and Drug Administration and GlaxoSmithKline, news releases, July 21, 2010


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

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:4/30/2016)... ... April 30, 2016 , ... Orlando-based Maximized Living has selected Dr. ... gold in Rio. Under the care of Maximized Living doctors at the London ... unprecedented showing, Maximized Living is sending the largest contingent of elite chiropractors to Rio ...
(Date:4/29/2016)... ... April 29, 2016 , ... In an article published ... her enthusiasm for Botox and lip injections, which she underwent in order to feel ... Valley Music and Arts Festival. The article explains that Ms. Mirmelli’s situation is not ...
(Date:4/29/2016)... ... April 29, 2016 , ... Shamangelic ... the addition Onnit brand Alpha BRAIN and New Mood Daily-Stress Formula for brain ... mood optimization products to the store is just one more way Shamangelic Healing ...
(Date:4/29/2016)... ... April 29, 2016 , ... The ... nation’s productivity, stability, even security. Most importantly, employees are the single most important ... are American workers so unhappy? , Just under half of American workers are ...
(Date:4/29/2016)... ... 29, 2016 , ... Conditions were ideal for Global Lyme Alliance’s (GLA) 2nd ... sunny skies, a light breeze and temperatures in the 60s. Over 400 runners, walkers ... and Walk and 1-mile walk were held to increase awareness about Lyme disease ...
Breaking Medicine News(10 mins):
(Date:4/29/2016)... BERLIN , April 29, 2016 ... world-leading glyco-biology expertise, today announces the appointment of Dr. ... Dr. Zurlo is an oncologist with many years ... pharmaceutical and biotechnology industries. His last role was at ... Member of the Executive Board. Previously Dr. Zurlo held ...
(Date:4/28/2016)... , April 28, 2016 Research ... "Global Plastic Surgery Products Market 2016-2020" report to ... ) , The global plastic surgery products ... 9.47% during the period 2016-2020. , ,The growing adoption ... to the growth of the market. Lasers are used ...
(Date:4/28/2016)... NEW YORK , April 28, 2016 ... of online consumer insights on healthcare, announced today that ... in their report Cool Vendor in Life Sciences, ... , April 15, 2016.  The report focuses on life-science- ... to gain insight from patients and doctors, confirm medication ...
Breaking Medicine Technology: