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Latest Rosiglitazone Stories

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2010-07-22 07:50:00

Federal health authorities are prohibiting new patients from enrolling in a safety study for GlaxoSmithKline's controversial diabetes pill Avandia, a week after an expert panel ruled that the drug increases heart risks. The Associated Press (AP) reported Wednesday that the Food and Drug Administration (FDA) said it issued a "partial clinical hold" on the study to update researchers on the latest concerns about the drug, which has been under a close eye since 2007. Although the panel of...

2010-07-15 14:42:26

The Endocrine Society, American Diabetes Association and American Association of Clinical Endocrinologists issue joint statement in response to an FDA panel's recommendation to keep rosiglitazone (Avandia) on the market The U.S. Food and Drug Administration's (FDA) Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee has completed their evaluation of the scientific research available on the safety of rosiglitazone....

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2010-07-15 06:05:00

A panel of U.S. Food and Drug Administration advisers voted Wednesday to allow GlaxoSmithKline's diabetes drug Avandia to remain on the market, but with new restrictions due to the risky cardiovascular side effects of the controversial pill. The panel of experts voted 20-12 to retain availability of Avandia to diabetics, although 10 panelists called for limiting who can receive and prescribe the once-blockbuster medication. British drugmaker Glaxo has been hit with thousands of lawsuits from...

2010-07-14 18:28:00

DALLAS, July 14 /PRNewswire-USNewswire/ -- After two days of hearings, an advisory committee to the U.S. Food and Drug Administration (FDA) recommended that the FDA allow the type 2 diabetes drug rosiglitazone (brand name, Avandia), to stay on the market, but with most committee members suggesting that the label be revised to include increased warnings. Rosiglitazone is one in a class of drugs called thiazolidinediones (TZDs), used to treat type 2 diabetes. (Logo:...

2010-07-14 17:19:00

DEERFIELD, Ill., July 14 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting primarily focused on reviewing the cardiovascular (CV) safety of rosiglitazone, as presented by the FDA and GlaxoSmithKline. Following this two day discussion, Takeda Pharmaceuticals North America, Inc. ("Takeda") underscores its position that ACTOS®...

2010-07-14 16:53:00

PHILADELPHIA, July 14 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions (20) to withdrawal from the U.S. market (12). "Following today's recommendations, we will, of course, continue...

86cee565efd865d6a24c9732f5d7e7b8
2010-07-13 13:37:42

GlaxoSmithKline Plc stood up for its diabetes pill Avandia against U.S. advisers this week, claiming that it was safe and should stay on the market. The scientific experts assembled by the U.S. Food and Drug Administration are sorting through cases to determine whether Avandia causes heart attacks. "Follow the science where it leads and the rest will fall into place," FDA Commissioner Margaret Hamburg said in the opening of a meeting held in a packed hotel ballroom, acknowledging that the...

2010-06-30 09:57:44

The diabetes drug rosiglitazone has been under intense scrutiny since a 2007 study in the New England Journal of Medicine looked at more than 40 clinical trials and linked the drug's use with increased risk of heart attack and death from heart disease. Now, in a post-trial analysis of results from an international clinical trial of 2,368 diabetes patients with cardiovascular disease, researchers at Washington University School of Medicine in St. Louis and several major centers across the...

2010-06-29 03:05:46

Eleven years after the introduction of the diabetes drug rosiglitazone, data from available clinical trials demonstrate an increased risk for heart attack associated with its use and suggest an unfavorable benefit-to-risk ratio, according to a report posted online today that will appear in the July 26 print issue of Archives of Internal Medicine, one of the JAMA/Archives journals. The study was published online in advance of an upcoming Food and Drug Administration meeting that will review...

2010-06-09 13:25:29

New research helps to explain why some commonly used drugs come with a serious downside: They up your odds of breaking a bone. The drugs in question, glucocorticoids (e.g. cortisone and prednisone) and the insulin sensitizer rosiglitazone work through entirely different mechanisms as therapies for inflammatory diseases and diabetes respectively, and two studies in the June issue of Cell Metabolism now show that they lead to bone loss in different ways too. Both research teams, one at the...


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pungle
  • To take pains; labor assiduously with little progress.
This word comes from the Spanish 'pongale,' put it.
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