Avandia FDA

List of Abbreviations in the Avandia FDA Advisory Committee Briefing Document

11 July, 2010

Avandia FDA Advisory Committee Briefing Document Abbreviations

AE		Adverse event
ACR		Albumin creatinine ratio
ACS		Acute Coronary Syndrome
BARI 2D	Bypass Angioplasty Revascularization Investigation 2 Diabetes

Category: Avandia FDA | Avandia News

Avandia safety risks FDA staff report, data to be released July 9, 2010

8 July, 2010

The FDA’s staff report on Avandia safety and all supporting data will be made public tomorrow. An Avandia recall may not be far behind

A report on Avandia safety risks is expected to be released tomorrow by the Food and Drug Administration. The future of the diabetes drug hangs in the balance. Critics claim Avandia heart risks outweigh its benefits and long have demanded an Avandia recall. Several scientific studies, including two released last week, have linked the drug to higher heart risks than other diabetes drugs. Continue reading Avandia safety risks FDA staff report, data to be released July 9, 2010

Category: Avandia FDA | Avandia News | Avandia Recall | Avandia Safety

Avandia study blocked: Dr. David Graham’s email to FDA Com. Margaret Hamburg

13 June, 2010

From: Graham, David J [mailto:David.Graham1@fda.hhs.gov]

Sent: Friday, May 28, 2010 3:31 PM

To: Hamburg, Margaret; Sharfstein, JM

Cc: Graham, David J

Subject: TZD study update

Dear Drs. Hamburg and Sharfstein,

Except for a few minor details, we have completed our study comparing
the cardiovascular risks of rosiglitazone vs. pioglitazone in Medicare elderly. Continue reading Avandia study blocked: Dr. David Graham's email to FDA Com. Margaret Hamburg

Category: Avandia FDA | Avandia News | Avandia Safety

Avandia settlements may exceed $1 billion

16 May, 2010

GlaxoSmithKline may pay more than $1 billion to settle Avandia lawsuits.
The defective drug litigation has reached the point where more Avandia settlements are expected in the near future. Continue reading Avandia settlements may exceed $1 billion

Category: Avandia FDA | Avandia Lawsuit

Leading drug safety expert to Congress: Recall Avandia and stop TIDE trial

2 May, 2010

In testimony to Congress, consumer group demands Avandia recall and halt to the TIDE drug safety trial

Dr. Sidney Wolfe, Director of the Health Research Group at the non-profit consumer advocacy group Public Citizen, testified that the health and safety of thousands of innocent people are being jeopardized by allowing the TIDE trial to continue. Continue reading Leading drug safety expert to Congress: Recall Avandia and stop TIDE trial

Category: Avandia FDA | Avandia News | Avandia Recall | Avandia Safety

Avandia recall threat takes financial toll on GlaxoSmithKline

30 April, 2010

Heart side effects concerns and the possible recall of Avandia have led to a significant drop in sales of the popular diabetes drug.

Despite earnings and revenue being up 9% and 17%, respectively, a possible FDA Avandia recall leads financial analysts describe Glaxo’s first-quarter report as “gloomy.” Continue reading Avandia recall threat takes financial toll on GlaxoSmithKline

Category: Avandia FDA | Avandia News | Avandia Recall

Assessment of Avandia Safety at July FDA meeting to lead to TIDE Trial decision

24 April, 2010

Avandia safety assessment at July meeting of joint FDA committees to lead to TIDE Trial decision.

When the FDA convenes a joint meeting of its Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory committees in July, the agency will assess the cardiovascular safety of Avandia and decide whether the controversial TIDE… Continue reading Assessment of Avandia Safety at July FDA meeting to lead to TIDE Trial decision

Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Senate Report

FDA may suspend Avandia safety study, could lead to Avandia recall

21 April, 2010

An Avandia safety study called the TIDE trial may be suspended by the FDA over Avandia heart attack risks.

Calls for an Avandia recall have been renewed over concerns that the diabetes drug increases heart risks. In February, a critical Senate report on Avandia was released following a two-year Senate Finance Committee investigation… Continue reading FDA may suspend Avandia safety study, could lead to Avandia recall

Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Senate Report

Avandia FDA Safety Alert – April 2009

15 March, 2010

FDA Issues Safety Alert on Avandia

The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related… Continue reading Avandia FDA Safety Alert - April 2009

Category: Avandia FDA

Avandia maker GlaxoSmithKline releases “White Paper Response” to Senate Report on Avandia

6 March, 2010

Avandia drug company GlaxoSmithKline defends its popular diabetes drug in a 30-page “white paper” released February 24 rejecting a recent Senate Report stating that GSK downplayed the safety risks of their diabetes treatment Avandia. The prescription drug maker attacks the Senate Finance Committee’s January 2010 report on Avandia, claiming it is inaccurate, unbalanced and gives Continue reading Avandia maker GlaxoSmithKline releases "White Paper Response" to Senate Report on Avandia

Category: Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Senate Report
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