RECORD readjudication rosy for rosiglitazone
A Duke University readjudication of the original trial suggests little difference from the original trial, which did not find
an increased CV risk for rosiglitazone.
Lipid/Metabolic, Aug 26, 2013
Rosiglitazone restrictions should be eased, says FDA advisory panel
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, Jun 6, 2013
FDA says again: Rosiglitazone does not up CV risk
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.
Lipid/Metabolic, Jun 6, 2013
Will new FDA meeting on Avandia prompt withdrawal of drug?
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.
Lipid/Metabolic, Apr 15, 2013
Rosiglitazone features in $3-billion healthcare-fraud case
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.
Medscape Medical News, Jul 3, 2012
More damning data on rosiglitazone
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.
Lipid/Metabolic, Mar 17, 2011
Switch pitch? Think beyond TZD ads when taking patients off rosiglitazone
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, Feb 22, 2011
New rosiglitazone label includes restrictions on use
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, Feb 7, 2011
GlaxoSmithKline settles Avandia lawsuit
GlaxoSmithKline has settled a lawsuit claiming that the diabetes drug rosiglitazone caused the death of a man in 2006.
Lipid/Metabolic, Feb 1, 2011
European regulators explain why they suspended rosiglitazone
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, Dec 14, 2010
Wide variation in response to FDA rosiglitazone warning
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.
Lipid/Metabolic, Nov 25, 2010
"A very complex, difficult history for the agency": The FDA on rosiglitazone
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.
MediaPulse, Oct 5, 2010
Reaction to rosiglitazone decisions mixed, but measured
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, Sep 24, 2010
FDA restricts rosiglitazone; EMA pulls the plug
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.
Lipid/Metabolic, Sep 23, 2010
Accusations of bias among FDA rosiglitazone panel
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, Sep 14, 2010
UK experts advised rosiglitazone withdrawal in July
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.
Lipid/Metabolic, Sep 8, 2010
Rosiglitazone, pioglitazone pose similar CV risk in case-matched analysis
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.
Lipid/Metabolic, Aug 24, 2010
Patients with diabetes have alternatives to rosiglitazone, experts say
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?
Medscape Medical News, Jul 22, 2010
FDA stops enrollment in TIDE trial
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.
Lipid/Metabolic, Jul 21, 2010
News report links Avandia panelists to drug makers
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.
Heart failure, Jul 20, 2010
Rosiglitazone meeting: Advisory committee delivers mixed message to FDA
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.
Lipid/Metabolic, Jul 15, 2010
Day one: Data deluge at FDA rosiglitazone review provides more questions than answers
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.
Lipid/Metabolic, Jul 13, 2010
More evidence against GSK and FDA on rosiglitazone
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.
MediaPulse, Jul 13, 2010
No letup for GSK: EMA set to review rosiglitazone
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.
Lipid/Metabolic, Jul 12, 2010
As rosiglitazone review looms, FDA documents slam RECORD and find significant risks for the drug
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, Jul 9, 2010