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VICTORY: "Reassuring" Atherosclerosis/Metabolic Data on Rosiglitazone
The drug showed a trend toward a slowing of the progression of atherosclerosis and an overall positive effect on metabolic factors in the VICTORY study in post-CABG diabetes patients.
News, April 2008
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FDA Reprimands GlaxoSmithKline Over Missing Data on Rosiglitazone
In a letter to GlaxoSmithKline, the FDA said that an inspection in late 2007 focusing on compliance with postmarketing adverse drug experience reporting requirements found that the company failed to report data from clinical usage and failed to disclose or submit data from clinical trials.
News, April 2008
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Two U.S. Pharmacy Benefit Managers Drop Glaxo's Avandia
Two U.S. pharmacy benefit managers said on Thursday they had dropped GlaxoSmithKline Plc's Avandia (rosiglitazone) from their national formularies due to safety concerns.
News, December 2007
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Rosiglitazone to Stay on US Market With New Warnings About MI
The US FDA adds new information to the existing boxed warning while safety assessment continues. The Canadian authorities have taken similar action, albeit with a more strongly worded warning.
News, November 2007
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Reuters Summit -- FDA Says Avandia Decision Due in Days
The U.S. Food and Drug Administration will announce its decision on GlaxoSmithKline Plc's diabetes drug Avandia within days, its deputy commissioner said Tuesday.
News, November 2007
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U.S. Senator Asks FDA About Internal Avandia Vote
A senior Republican lawmaker asked the U.S. Food and Drug Administration to confirm that an internal FDA group privately voted to keep the troubled diabetes drug Avandia on the market by a one-vote margin, according to a letter made public on Monday.
News, October 2007
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FDA Eyes New Boxed Warning on Glaxo's Avandia: WSJ
U.S. Food and Drug Administration officials are pushing for a "black box" warning of the risk of MI on GlaxoSmithKline Plc's diabetes drug Avandia (rosiglitazone), the Wall Street Journal reported on Wednesday, citing unnamed sources.
News, October 2007
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U.S. Veterans Dept to Limit Glaxo's Avandia: NYT
The U.S. Department of Veterans Affairs has decided to "severely limit" the use of GlaxoSmithKline Plc's diabetes drug Avandia over safety concerns, the New York Times reported on Wednesday.
News, October 2007
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Glitazones Increase Heart Failure but Not Mortality in New Meta-Analysis
A new meta-analysis of studies with the diabetes drugs rosiglitazone and pioglitazone has shown an increased risk of heart failure but no increase in cardiovascular death with these drugs.
News, September 2007
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Fresh Fuel for the Glitazone Controversy: New Pioglitazone and Rosiglitazone Meta-Analyses
One study shines the spotlight on pioglitazone, suggesting that it may indeed have a better safety profile than rosiglitazone, at least in terms of ischemic events, while yet another meta-analysis of rosiglitazone, looking only at studies in diabetics, reaffirms the increased risk of MI seen in other recent studies.
News, September 2007
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Rosiglitazone Wrangling Continues in NEJM Correspondence
Letters to the editor published in this week's print issue of the journal quibble with the statistical methods used in Nissen and Wolski's original meta-analysis, while online letters trade barbs over a subsequent rosiglitazone Perspective.
News, August 2007
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Recalls & Warnings Black-Box Heart-Failure Warning for Rosiglitazone, Pioglitazone
The FDA says it is still mulling over the signal of increased ischemic events with rosiglitazone, but the new label makes no mention of this.
August 2007
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Reanalysis of Nissen/Wolski Rosiglitazone Meta-Analysis Scrutinizes Findings, Methods
A new analysis of the same 42 trials, but using a number of different statistical methods to account for all the zero events, found no significant increase in either MI or CV death and highlights flaws in the original study. In response, Nissen counters that the report is now neither useful nor relevant in the wake of the FDA hearing.
News, August 2007
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Rosiglitazone Story a Reminder of Need for FDA Reform
Dr Clifford Rosen, who chaired the recent FDA panel meeting, says rosiglitazone's rise and fall highlight the need for a tougher preapproval process, and postmarketing trials with teeth.
News, August 2007
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FDA to Ask If Avandia Should Stay on Market
The Food and Drug Administration will ask outside advisers if GlaxoSmithKline Plc's diabetes drug Avandia should stay on the market or be subject to new warnings or limits, a summary released on Thursday said.
News, July 2007
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Cochrane Review Urges Caution on Rosiglitazone Use
The new review found no evidence of any benefits with the drug over other available treatments for diabetes and, because of side effects such as edema, fractures, and possible increased risk of MI, recommends that other antidiabetic medications be used in preference.
News, July 2007
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Higher Cancer Prevalence Seen Among Diabetics Taking Thiazolidinediones
Patients with diabetes, especially women, who take thiazolidinediones (TZDs) may have an increased risk of developing cancer, according to a report in the June 21st publication of BMC Medicine.
News, July 2007
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ADOPT Analysis Shows Rosiglitazone Increases Risk of Fracture in Women
Not unlike a prizefighter battered and bruised, rosiglitazone continued to take it on the chin this week with an analysis of ADOPT expanding upon the increased risk of fracture among diabetic women taking the controversial TZD.
News, June 2007
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Rosiglitazone: Policy Implications and Continuing Debate
The rosiglitazone saga has led to more calls for reform of the FDA, the latest coming from drug safety expert Dr Brian Strom and former FDA commissioner Dr Donald Kennedy. While Strom and Kennedy concur that changes are needed at the FDA, they disagree on the merits of Nissen’s meta-analysis. Dr Valentin Fuster also comments on the rosiglitazone saga.
News, June 2007
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Nissen Responds to Rosiglitazone Debate at ADA Meeting
Much in the spotlight in the past month, Dr. Steven Nissen's audience this time, instead of politicians on Capitol Hill, was a house full of physicians and researchers in a hastily added panel discussion.
News, June 2007
