07/28/2010
Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug's maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company's $3 billion-a-year blockbuster drug caused heart problems was inconclusive. To do that, the GSK officials focused not on heart-attack data but on a broader, less well defined category of heart problems called myocardial ischemia.
07/23/2010
More than nine out of 10 scientists who backed a drug at the centre of a safety scare had financial links to the pharmaceutical industry, a study has found.
07/20/2010
One of the three panelists who recommended that the U.S. Food and Drug Administration allow GlaxoSmithKline to continue marketing Avandia with no further restrictions is a paid speaker for the drug company, reports The Wall Street Journal.
07/16/2010 It remains unclear whether the most closely watched FDA advisory panel in years will prove to be the death knell or a life raft for rosiglitazone.
07/14/2010
Federal advisers delivered a mixed verdict Wednesday on the diabetes drug Avandia, with a significant number of experts voting to recommend that it be pulled from the market because of safety concerns but a majority urging to keep it available, perhaps with tough new restrictions and new warnings.
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Avandia Side Effects Lawsuit NO RECOVERY... NO FEES...NO COSTS
Avandia - Rosiglitazone is a widely prescribed medication to treat Type-2 Diabetes Mellitus, a condition which also known as Adult-Onset Diabetes. Manufactured by GlaxoSmithKline, Avandia (Rosiglitazone) was approved for the treatment of Type-2 Diabetes in the U.S. in 1999. Avandia is also contained in combination with other drugs in medications called Avandryl and Avandamet. To date, more than six (6) million people worldwide have taken the drug, and Avandia generates approximately $3.2 billion in annual sales for its manufacturer. However, on May 21, 2007, the United States Food & Drug Administration ("FDA") issued a Safety Alert regarding Avandia. Later, on November 17, 2007 a "Black Box Warning" was issued by the FDA about a potential increase in heart attacks and heart-related chest pain in some
individuals using Avandia.
The FDA Safety Alert warns that patients who are taking Avandia (rosiglitazone) - especially those who are known to have underlying heart disease or who are at high risk of heart attack (myocardial infarction) - should speak to their physicians about their continued use of Avandia.
The FDA's Safety Alert follows a study released on the same day, which will appear in the June 14, 2007 issue of the New England Journal of Medicine. This type of study, known as a 'meta-analysis', evaluated forty-two (42) separate studies comparing patients using Avandia (rosiglitazone) to patients who were not using Avandia. This study concludes that patients taking Avandia (rosiglitazone) face a 43% increased risk of heart attack, and a 64% increased risk of dying from heart related ( cardiovascular) disease. Cardiovascular disease refers to the class of diseases that affect the heart and/or blood vessels, which includes but is not limited to heart attacks (myocardial infarction), strokes, aneurysms, congestive heart failure, and arrhythmia. As indicated above, there has not yet been a recall, nor has the FDA yet required that the manufacturer issue a black box warning label for Avandia, but in the event Avandia is subjected to a recall, this site will be updated.
If you or a loved one have experienced an Avandia heart attack, or Avandia stroke, Avandia congestive heart failure, Avandia cardiovascular disease or if you have lost a loved one to an Avandia death you may be entitled to compensation. Contact the Avandia lawyers of Ennis & Ennis, P.A. today about an Avandia lawsuit. Call us toll free for a free, confidential case evaluation or fill out our online Avandia case evaluation form on this page.