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:6/26/2016)... Charlotte, NC (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind ... able to be personalized through a fitness app. The fitness app plans to fix the ... solutions currently only offer a one size fits all type program , They ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the ... several important health care topics including advance care planning, healthcare costs and patient ...
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room ... Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Research and Markets has announced the addition of ... report to their offering. ... kidney failure, it replaces the function of kidneys by removing ... thus the treatment helps to keep the patient body,s electrolytes ... Increasing number of ESRD patients & substantial healthcare expenditure ...
(Date:6/23/2016)... 2016 Research and Markets has ... by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), ... Parenteral) - Global Forecast to 2021" report to ... The global pharmaceutical excipients market is projected to reach ... 6.1% in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... 23, 2016 Roche (SIX: RO, ROG; OTCQX: ... its Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated ... shock. With this clearance, Roche is the first IVD ... solution for sepsis risk assessment and management. ... and PCT levels in blood can aid clinicians in ...
Breaking Medicine Technology: