Posts tagged with: "avandia-lawsuit"
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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]
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]
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]
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: 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]
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]
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]
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]
20 Jan 2011, 3:53 am by Mark Zamora
Image via WikipediaInteresting read which should lead as a discussion point for some lawyers. In a recent post, the author commented on the legal bills related to each drug. GSK has spent $6 Billion to defend cases involving Avandia while Merck spent $4 Billion to settle all of Vioxx.Read it here: Link.  [read post]
22 Jul 2010, 4:23 pm by Mark Zamora
Image via CrunchBaseThe FDA has ordered drug maker GlaxoSmithKline to stop enrolling new patients in a  clinical trial of its d diabetes drug, Avandia.The clinical trial, called TIDE, was mandated by the FDA to assess safety risks of the drug, which is prescribed to treat type-2 diabetes.The FDA said the action does not mean the drug will be removed from the market. But the agency is demanding that GlaxoSmithKline update physicians and ethics oversight boards involved in the trial regarding … [read post]
25 Feb 2010, 1:37 pm by Mark Zamora
Image by neofedex via FlickrFrom the Institute for Safe Medicine Practices: Rosiglitazone (AVANDIA). More than 1000 reports of patient deaths were received forrosiglitazone in the first three quarters of 2009, more than any other drug we monitor. Rosiglitazone is an oral medication for treating Type 2 or adult onset diabetes. Most deaths were attributed to cardiovascular causes, a problem for which the FDA has required warnings. While these cases do not appear to signal previously undetected risks… [read post]
26 Oct 2010, 12:28 pm by Mark Zamora
The maker of Avandia -- GSK --- has received from the Department of Justice more than one subpoena. Several U.S. states are also considering action against the company, and new claims from patients hit the courts regularly.Avandia, the once-top-selling diabetes drug, has been plagued by safety concerns since 2007. After several years of weighing data and more data, regulators in Europe chose to pull the drug off the market completely, while FDA put severe restrictions on its use. The company … [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]
25 Mar 2010, 10:06 am by Greenberg & Bederman
  Studies Refuting Avandia Heart Attack Evidence Authored By Drug Company Scientists When the FDA released a warning about the type 2 diabetes drug Avandia in April of 2009, the premise of the warning was quite clear: “Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.” Although the FDA did not take any steps toward removing Avandia from the shelves of the… [read post]
15 Jul 2011, 3:44 pm by admin
Class Action Suit for Avandia in Illinois Avandia is a target for over 40 lawsuits filed in Illinois that were filed in St. Clair County Circuit Court in May 2011. There are many other lawsuits throughout the U.S. against the makers of Avandia, a diabetes medication linked to cardiovascular disease and heart attack manufactured by GlaxoSmithKline. It is contended that GlaxoSmithKline aware of the risk in 2005 but did not properly inform the public. Therefore, people were not permitted to make a well… [read post]
13 Jul 2010, 11:46 am by Tom Lamb
During July 13-14, 2010 FDA Advisory Committee Meeting, Glaxo Settles Most Of The 13,000 Avandia Court Cases (Posted by Tom Lamb at Bloomberg reporters Jef Feeley and Trista Kelley broke the news of a large (in terms of the number of claims, at least) Avandia settlement while most of the media's attention was on the July 13-14, 2010 FDA Advisory Committee meeting about whether Avandia should remain on the market in the U.S. or be recalled. From this July 13, 2010 Bloomberg… [read post]