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Rosiglitazone wrangling
A controversial 2007 meta-analysis questioning the cardiovascular safety of rosiglitazone opened a Pandora's box for what had been a blockbuster diabetes drug. The story has involved analyses and reanalyses of trial data, accusations of investigator intimidation, FDA and US Senate investigations, black-box warnings, leaked academic papers, accusations of missing data, and wiretapped discussions with the drug manufacturer--all culminating in calls to pull the drug from the market and stop the only trial that might decisively answer the questions that have dogged this drug.
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Rosiglitazone restrictions should be eased, says FDA advisory panel
Lipid/Metabolic
Rosiglitazone restrictions should be eased, says FDA advisory panel
2 COMMENTS - Jun 6, 2013 21:45 EDT
Influenced by a recent RECORD readjudication showing lack of significant harm, a joint FDA advisory panel voted to keep rosiglitazone on the US market and to ease current prescribing restrictions but not remove them entirely.
Lipid/Metabolic
FDA says again: Rosiglitazone does not up CV risk 
5 COMMENTS - Jun 6, 2013 12:15 EDT
The first day of a two-day meeting on rosiglitazone included presentations from the FDA, GlaxoSmithKline, Duke University reviewers, and one dissenting FDA official. Today the panel will vote on the drug's future.
Will new FDA meeting on Avandia prompt withdrawal of drug?
Lipid/Metabolic
Will new FDA meeting on Avandia prompt withdrawal of drug?
4 COMMENTS - Apr 15, 2013 14:15 EDT
The FDA has announced that two of its panels will discuss the reanalysis of the controversial RECORD trial with the much-maligned diabetes drug rosiglitazone in June.
Medscape Medical News
Rosiglitazone features in $3-billion healthcare-fraud case
7 COMMENTS - Jul 3, 2012 12:15 EDT
GlaxoSmithKline has settled civil charges and pleaded guilty to criminal charges of promoting off-label uses of two drugs and failing to disclose negative safety data on a third to the FDA.
Lipid/Metabolic
More damning data on rosiglitazone
6 COMMENTS - Mar 17, 2011 18:30 EDT
A new meta-analysis of observational studies shows rosiglitazone to be associated with a higher risk of heart failure, MI, and death than pioglitazone. But despite having been taken off the market in Europe, the REMS restriction for rosiglitazone recommended by the US FDA last September has still not been finalized.
Switch pitch? Think beyond TZD ads when taking patients off rosiglitazone
Lipid/Metabolic
Switch pitch? Think beyond TZD ads when taking patients off rosiglitazone
11 COMMENTS - Feb 22, 2011 16:45 EST
Physicians who may have seen a sweeping ad campaign unleashed by Takeda when FDA advisors delivered their mostly negative view of rosiglitazone last year should consider other drug classes or lifestyle changes, rather than defaulting to pioglitazone, a new paper argues.
Lipid/Metabolic
New rosiglitazone label includes restrictions on use
Feb 7, 2011 17:00 EST
The new label has been changed to highlight the increased cardiovascular risks with the drug, noting that in a meta-analysis of 52 studies, most of which compared rosiglitazone with placebo, the drug was associated with a significantly increased risk of MI.
Lipid/Metabolic
GlaxoSmithKline settles Avandia lawsuit
3 COMMENTS - Feb 1, 2011 13:45 EST
GlaxoSmithKline has settled a lawsuit claiming that the diabetes drug rosiglitazone caused the death of a man in 2006.
European regulators explain why they suspended rosiglitazone
Lipid/Metabolic
European regulators explain why they suspended rosiglitazone
Dec 14, 2010 17:15 EST
Regulators from various agencies, including the European Medicines Agency, explain their September 2010 decision to suspend marketing authorization for rosiglitazone in a paper that highlights what evidence was considered in that process, stating that the drug was removed because "benefits of rosiglitazone no longer outweigh the risks."
Lipid/Metabolic
Wide variation in response to FDA rosiglitazone warning
6 COMMENTS - Nov 25, 2010 10:30 EST
Doctors do not respond adequately to FDA boxed warnings on drug labels, resulting in significant exposure of patients to potentially unsafe medications, according to researchers, who use the rosiglitazone saga as an example.
MediaPulse
"A very complex, difficult history for the agency": The FDA on rosiglitazone
3 COMMENTS - Oct 5, 2010 13:30 EDT
Dr Joshua Sharfstein, principal deputy commissioner of the FDA, discusses the recent FDA decision to allow Avandia to stay on the market with restricted access and compares the decision with the European approach that suspended the drug.
Reaction to rosiglitazone decisions mixed, but measured
Lipid/Metabolic
Reaction to rosiglitazone decisions mixed, but measured
18 COMMENTS - Sep 24, 2010 08:45 EDT
Diabetes doctors convened at the EASD meeting in Stockholm have given their verdict on the differing decisions made by the European and American regulatory authorities yesterday on the fate of rosiglitazone. In the US, Nissen says he is "pleased" by the EMA actions; the FDA moves are "reasonable," he added.
Lipid/Metabolic
FDA restricts rosiglitazone; EMA pulls the plug
13 COMMENTS - Sep 23, 2010 11:50 EDT
UPDATED // After months of deliberations, the FDA has opted to allow Avandia to stay on the market, but only with severe restrictions. It also opted to stop the TIDE trial, pending a rereview of the RECORD trial. In contrast, the EMA has ordered the suspension of all rosiglitazone-containing products.
Accusations of bias among FDA rosiglitazone panel
Lipid/Metabolic
Accusations of bias among FDA rosiglitazone panel
12 COMMENTS - Sep 14, 2010 10:30 EDT
Two employees of the FDA have raised questions about members of a previous advisory panel who had already voted to keep rosiglitazone on the market being invited to the recent review meeting to decide the future of the drug.
Lipid/Metabolic
UK experts advised rosiglitazone withdrawal in July
2 COMMENTS - Sep 8, 2010 15:30 EDT
It has emerged this week that UK experts recommended the withdrawal of the diabetes drug rosiglitazone from the British market in July, although this recommendation was not made public at the time. However, because the drug was approved centrally by the European Medicines Agency, only it can revoke the license, says the UK regulatory body; the EMA is discussing rosiglitazone today, although no final decision is expected on the product until the end of this month.
Rosiglitazone, pioglitazone pose similar CV risk in case-matched analysis
Lipid/Metabolic
Rosiglitazone, pioglitazone pose similar CV risk in case-matched analysis
5 COMMENTS - Aug 24, 2010 17:00 EDT
The study isn't a substitute for a bona fide prospective randomized trial, but it is large and controlled for a lot of potential confounders. Why its conclusions contrast with those of some prior studies isn't known for sure, but there's at least one good possible reason.
Medscape Medical News
Patients with diabetes have alternatives to rosiglitazone, experts say
7 COMMENTS - Jul 22, 2010 16:30 EDT
Following the recent controversial FDA advisory panel decision on rosiglitazone, the drug's future availability is uncertain. But how much does that matter to the treatment of most patients with type 2 diabetes?
Lipid/Metabolic
FDA stops enrollment in TIDE trial
Jul 21, 2010 15:30 EDT
Enrollment in the controversial study assessing the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone has been stopped at the FDA's request.
Heart failure
News report links Avandia panelists to drug makers
9 COMMENTS - Jul 20, 2010 17:30 EDT
Dr David Capuzzi earned $14 750 as a member of the company's speakers' bureau but received the money related to talks about Lovaza and not for rosiglitazone. Dr Abraham Thomas received a few thousand dollars for speaking on behalf of pioglitazone, Avandia's rival.
Rosiglitazone meeting: Advisory committee delivers mixed message to FDA
Lipid/Metabolic
Rosiglitazone meeting: Advisory committee delivers mixed message to FDA
17 COMMENTS - Jul 15, 2010 07:15 EDT
UPDATED // Near the end of two days of exhaustive, often-polarized debate, 12 panel members said the drug should be withdrawn, with no other choice getting as many votes. But the other 20 votes were spread across three out of four other options, all suggesting that the drug could stay on the market, with certain provisions.
Day one: Data deluge at FDA rosiglitazone review provides more questions than answers
Lipid/Metabolic
Day one: Data deluge at FDA rosiglitazone review provides more questions than answers
3 COMMENTS - Jul 13, 2010 19:51 EDT
UPDATED // A marathon of 11 hours of presentations has likely left the joint Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees reeling in confusion. Day two promises more time for questions and reflection before the all-important vote.
More evidence against GSK and FDA on rosiglitazone
MediaPulse
More evidence against GSK and FDA on rosiglitazone
Jul 13, 2010 11:40 EDT
Details emerging from the Grassley investigation suggest that GlaxoSmithKline concealed early cardiac data and the FDA conspired with the company to minimize the impact of later safety results.
Lipid/Metabolic
No letup for GSK: EMA set to review rosiglitazone
2 COMMENTS - Jul 12, 2010 09:30 EDT
If GlaxoSmithKline thought today was its last chance to take a breath before the onslaught of the two-day safety hearing on its diabetes drug Avandia by a joint FDA advisory committee, starting tomorrow, it was mistaken. In the latest twist to this long-running saga, it emerged that the European Medicines Agency is also to review the drug's safety this summer.
As rosiglitazone review looms, FDA documents slam RECORD and find significant risks for the drug
Lipid/Metabolic
As rosiglitazone review looms, FDA documents slam RECORD and find significant risks for the drug
8 COMMENTS - Jul 9, 2010 09:00 EDT
UPDATED // The FDA documents, which provide a glimpse of what the agency's presentations will look like next week, are largely critical of rosiglitazone's safety record and of the ethics of the ongoing TIDE trial. In sharp contrast, GlaxoSmithKline's documents reiterate the need for a randomized controlled trial to resolve uncertainties and conclude that by and large the data support "the overall positive risk profile of rosiglitazone."
Lipid/Metabolic
BARI 2D analysis enters rosiglitazone debate, finds no MI hazard
3 COMMENTS - Jun 29, 2010 11:45 EDT
Investigators with the trial gave reporters at the ADA 2010 Scientific Sessions a cursory preview of a post hoc analysis to be reported in more detail later in the meeting: the controversial drug apparently wasn't associated with an excess risk of MI or other cardiovascular events in the BARI 2D trial. The finding, with all its limitations, adds to an already-contentious debate about the drug's safety.

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