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Avandia may cause serious or even life-threatening heart problems

10. July 2010

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Two new studies suggest Avandia may cause serious heart problems. FDA will reveal on Friday the data it is reviewing ahead of an advisory panel meeting about the safety of the popular diabetes drug. The meeting, scheduled for July 13 and 14, comes on the heels of two new studies suggesting that Avandia may cause serious or [...]

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Avandia may cause heart attacks

10. July 2010

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GlaxoSmithKline misinterpreted crucial details of a study finding that Avandia, its blockbuster diabetes drug, is safe, a medical reviewer for the Food and Drug Administration said Friday. Correctly interpreted, the study actually supports critics’ contentions that Avandia may cause heart attacks, said the reviewer, Dr. Thomas Marciniak, in a posting on the F.D.A.’s Web site. The company’s misreadings of the study, [...]

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Illegal marketing costs AstraZeneca $520 million

27. April 2010

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The settlement centers on the Delaware-based company’s efforts to promote Seroquel, which the Food and Drug Administration has approved to treat disorders such as schizophrenia and bipolar depression. The government alleges that AstraZeneca aggressively marketed the drug for unapproved uses — such as to treat Alzheimer’s disease and anxiety — to physicians, who then put [...]

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Government report links Avandia to heart attacks

20. February 2010

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The diabetes drug Avandia produced by GlaxoSmithKline is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, according to a Senate committee report released on 20., February of 2010. The senate report by the Senate Finance Committee also criticized the FDA, [...]

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FDA Warns Bioniche on Sotradecol Promotions

27. October 2009

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FDA sent Bioniche Pharm a written warning notice for a series of websites promoting its varicose vein treatment Sotradecol. In the letter, the FDA said that it reviewed two Sotradecol web pages located on the Bioniche Pharma website (www.sotradecolusa.com or “Bioniche web page”) and the AngioDynamics, Inc. website (www.angiodynamics.com/pages/products/Sotradecol.asp or “AngioDynamics web page”) as part of its [...]

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Avandia Drug Recall

20. January 2009

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Avandia produced by GlaxoSmithKline, is an oral diabetes medication intended to help those with type-2 diabetes better control their blood glucose levels. Generically classified as a thiazoliodinedione, Avandia is not indicated for those with insulin-dependent (type-1) diabetes. FDA scientists estimated in July 2007 that Avandia was associated with approximately 83,000 heart attacks since the drug came to [...]

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Merck’s Vioxx $4.85 billion payouts to begin in August

27. July 2008

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Merck & Company will begin funding cto resolve state and federal claims over its painkiller Vioxx.  The first payment of $500 million is scheduled for August 6; additional payments will follow.  Merck said it met its threshold to make these payouts and waived its right to walk away from last November’s agreement to settle roughly [...]

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FDA recalls Zyprexa

27. July 2008

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Zyprexa was FDA approved for the short-term treatment of acute manic episodes in bipolar disorder. The worlds best selling schizophrenia drug, Zyprexa sales account for 40% of Eli Lillys $11.08 billion in sales. There have been many questions regarding the popular drug Zyprexa and its safety. Linked to 288 reported Zyprexa diabetes cases, including 23 [...]

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Merck recalls Vioxx

27. July 2008

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Arthritis drug Vioxx (Rofecoxib) has been voluntarily recalled by Merck & Co Inc. worldwide. The move to pull the COX-2 inhibitor off the market on September 30, 2004 shocked the arthritis world and rocked the stock value of Merck. The Reason The decision to recall Vioxx followed a three year trial, known as APPROVe (Adenomatous Polyp Prevention on [...]

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Arthritis Drug Vioxx Recalled

27. July 2008

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Arthritis drug Vioxx (Rofecoxib) was recalled by Merck & Co., Inc. The Vioxx recall was voluntarily started by Merck to discontinue the COX-2 inhibitor in September, 2004. Person’s affected by the Vioxx side effects are urged to seek medical and legal help. The Vioxx Recall was prompted after a three year trial known as Adenomatous Polyp [...]

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