Posts tagged with: "Avandia"
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28 Sep 2010, 7:37 am by Mark Zamora
From Fortune and CNN/Money:Avandia has taken some beatings over the years, but it pretty much took a fatal blow yesterday. That's when the Food and Drug Administration ruled to keep the drug on the market in the United States with some serious restrictions.Those being: GlaxoSmithKline (GSK), the drug's manufacturer, can't promote it. Patients currently on the drug will be advised to switch to another similar treatment, if possible. Doctors can't prescribe Avandia to new patients without … [read post]
2 Sep 2010, 7:01 am by Mark Zamora
Image by neofedex via FlickrA new report says patients began discussing the risks of GlaxoSmithKline diabetes drug Avandia in online forums and blogs well before a meta-analysis linked it to higher heart-attack risk. Neither physicians nor company officials acknowledged their worries, contributing to an alarming drop in patient sentiment and, according to authors, a lost opportunity to reach out and restore trust.Patients first started questioning whether it was safe to take Avandia given… [read post]
9 Sep 2010, 6:54 pm by Mark Zamora
The diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) is once again in the media spotlight  in the UK, where it has emerged that experts from the UK Commission on Human Medicines (CHM) decided unanimously at the end of July that the drug should be withdrawn.This recommendation was not made public, however, in line with protocol. It was communicated to the British drug-licensing agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), which instead sent out "Dear doctor"… [read post]
6 Jun 2010, 6:19 pm by Mark Zamora
Image by neofedex via FlickrGlaxoSmithKline Plc (GSK.L) has settled more lawsuits alleging its Avandia diabetes drug caused heart attacks, heading off the first trial in the United States concerning the medicine.The company said on Tuesday that terms of the settlement remained confidential. It declined to specify how many claimants were involved."We can confirm that the case that was scheduled for the first trial in state court in Philadelphia, for June 1, 2010, has been settled," company… [read post]
18 Apr 2010, 6:55 pm by Mark Zamora
According to the Wall Street Journal report, FDA commissioner Margaret Hamburg wrote a letter to Grassley in late March saying that the agency is reassessing a trial that compares the drug to a drug made by Takeda Pharmaceutical Co called Actos. That trial is also called the TIDE trial, according to the Journal.FDA Principal Deputy Commissioner Joshua Sharfstein told the Journal that the decision on the trial "cannot be de-linked from the agency's view of Avandia."Sharfstein said no decision had… [read post]
28 Mar 2010, 7:35 am by Mark Zamora
A few years ago, the “New England Journal of Medicine", published a study that identified a potential heart risk with Glaxo’s then-blockbuster diabetes pill, Avandia.In an editorial in the latest issue of "The Journal of the American Medical Association" or JAMA, Drs. Catherine DeAngelis and Phil Fontanarosa call what happened “a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial. The circumstances represent another example of corporate motives… [read post]
18 Jul 2010, 5:47 pm by Mark Zamora
Avandia survives another round of FDA meetings. An FDA panel  panel took six votes on a variety of issues, but its most important came near the end of the meeting when asked what the FDA should do. Sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s… [read post]
30 Mar 2010, 5:34 pm by Mark Zamora
From the HuffPo:Diabetes is particularly detrimental to the heart, and heart problems are the eventual cause of death for most patients with diabetes. Given this, it is extremely worrisome that Avandia, a drug marketed to treat diabetes, has been found to harm the heart.The recognition that drugs can cause harm is nothing new. A recent example is the painkiller Vioxx which was found to harm the heart and taken off the market in 2004.While many extremely toxic drugs are eventually taken off the… [read post]
23 Sep 2010, 1:43 pm by Brenda Fulmer
The Food and Drug Administration and European drug regulators made a major announcement today that will affect more than half a million Type 2 diabetics currently using Avandia, or its generic form rosiglitazone, to control their blood sugar. Although manufacturer, GlaxoSmithKline, has continued to stand behind the drug, Avandia has been under scrutiny for years. A New England Journal of Medicine study released in May 2007 first indicated an increased risk for conditions such as cardiovascular… [read post]
12 May 2010, 8:42 pm by Mark Zamora
Image by neofedex via FlickrGlaxoSmithKline Plc agreed to pay about $60 million in the first settlements of lawsuits alleging the company’s Avandia diabetes drug causes heart attacks and strokes in some users.Avandia has been in the spotlight recently, following reports from various studies linking the drug to cardiovascular complications. The FDA estimates that Avandia treatment caused at least 83,000 heart attacks from 1999 to 2007, and clinical studies have shown that Avandia increases the risk… [read post]
28 Apr 2010, 6:01 pm by Mark Zamora
From: http://www.theheart.org/article/1069095.doLooks like folks will have to wait until July of 2010 to see if the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial, commissioned by the FDA and pitting rosiglitazone against pioglitazone (Actos, Takeda Pharmaceuticals), will be allowed to continue.There are concerns about whether or not the informed consent forms are up to snuff: "If people were to reexamine the informed-consent forms, particularly in light of the data as of… [read post]
5 Mar 2010, 5:44 am by Jim Reed
When will these drug manufacturers learn that it is NOT acceptable to keep distributing a drug they KNOW is causing injury and death? Haven’t they learned anything from the asbestos cases, the Vioxx cases, the Levaquin cases? The bottom line is that they will NOT be able to conceal damaging information forever. In today’s age of free exchange of information, it is becoming more difficult than ever for any manufacturer to keep a lid on problems with their products. In the old days, a heart… [read post]
18 Jan 2011, 6:01 am by Mark Zamora
Image by neofedex via FlickrThere is news that Glaxo  will have fourth-quarter legal costs of $3.5 billion because of investigations into sales practices for certain products and product-liability cases related to Avandia, a diabetes drug.The company will be putting aside additional monies for other investigations, including one by the U.S. attorney in Colorado into the company’s sales and promotional practices of certain products.The troubles mount for Glaxo, and this report simply shows the… [read post]
4 Dec 2010, 12:53 pm by Ed Wallis
ATTENTION RESIDENTS OF ALL FIFTY STATES -  FREE CASE EVALUATION – FREE LAWYER CONSULTATION – CALL TOLL FREE 1-800-632-1404 Citing industry executives and experts, Reuters (11/13, Richwine) reported that regulators apparently are now paying more attention to risks posed by drug products in the aftermath of some controversial cases, including the diabetes pill Avandia (rosiglitazone). For example, Novo Nordisk A/S received approval for its diabetes drug Victoza (liraglutide) earlier this year… [read post]
4 Dec 2010, 12:55 pm by Ed Wallis
ATTENTION RESIDENTS OF ALL FIFTY STATES -  FREE CASE EVALUATION – FREE LAWYER CONSULTATION – CALL TOLL FREE 1-800-632-1404 At Mother Jones (9/29), Paul D. Thacker discussed in detail his time “as the lead investigator for Sen. Chuck Grassley (R-Iowa) on the Senate Finance Committee’s investigation into” GlaxoSmithKline’s Avandia. “What emerged was a troubling picture of a company that had placed corporate profits over patient safety. While suppressing inconvenient evidence about the… [read post]
30 Apr 2010, 4:11 am by Mark Zamora
Amazing. You just have to read the report released yesterday. From the Senate Report:Senators "asked the Food and Drug Administration to describe what steps the agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. In 2008, FDA officials called the clinical trial, as then-designed, “unethical and exploitative” of… [read post]
31 Mar 2010, 6:34 am by Greenberg & Bederman
Things are starting to look somewhat bleak for GlaxoSmithKline. Of course, the definition of “bleak” takes on a different meaning when you happen to be a multibillion dollar pharmaceutical conglomerate. For you or me, “bleak” might mean facing bankruptcy, or having a relative in the hospital, or any number of serious, life changing events. For GSK, “bleak” means “only making hundreds of millions instead of billions.” This is the sort of “bleak” that pretty much everybody we know… [read post]
20 Oct 2010, 7:28 am by Mark Zamora
A good report from American Counsel on Science and Health:As drugs continue to be taken for longer periods of time, unexpected complications may arise that were absent from short-term clinical trials. New York Times science journalist Gina Kolata reported on what happens when drugs cause problems they were originally developed to prevent, focusing on the risks associated with the now highly restricted diabetes drug Avandia, and bisphosphonates, a class of medicine used to treat… [read post]
4 Dec 2010, 12:56 pm by Ed Wallis
ATTENTION RESIDENTS OF ALL FIFTY STATES -  FREE CASE EVALUATION – FREE LAWYER CONSULTATION – CALL TOLL FREE 1-800-632-1404 The AP (10/22, Perrone) reports, “British drugmaker GlaxoSmithKline (GSK) reported Thursday that its controversial diabetes drug Avandia [rosiglitazone] is under investigation by federal and state law enforcement officials in the US.” The news “came less than a month after the Food and Drug Administration issued severe restrictions on use of Avandia because of its… [read post]
22 Feb 2010, 4:19 am by Jonathan Rosenfeld
New reports to be issued following a Senate investigation and results from a clinical trial appear to further solidify the dangers associated with Avandia (rosiglitazone).  As cited by The New York Times, the reports conclude that if Avandia patients switched to a similar diabetes drug, Actos, approximately 500 heart attacks and 300 cases of heart failure could be avoided every month. These recent studies are just the latest in an extensive series of studies that have been critical of both the… [read post]