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Latest Rosiglitazone Stories

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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...

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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...

2010-02-24 09:24:00

RESEARCH TRIANGLE PARK, N.C., Feb. 24 /PRNewswire-FirstCall/ -- Today, GlaxoSmithKline (NYSE: GSK) responded to the recently released Senate Committee on Finance's January 2010 "Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia" (the "Staff Report"). To view GSK's response, visit http://www.gsk.com/media/GSK-White-Paper-Avandia-23-Feb-2010.pdf. In its response, GSK states that the Staff Report fails to present an accurate, balanced, or complete view of the currently available...

2010-02-23 15:42:00

DALLAS, Feb. 23 /PRNewswire-USNewswire/ -- The data are inconclusive on heart risks from a class of blood sugar-lowering drugs called thiazolidinediones (TZDs) such as pioglitazone (Actos) or rosiglitazone (Avandia), but the medications should be used with close monitoring from healthcare providers according to a joint science advisory from the American College of Cardiology and the American Heart Association. The advisory is published online in both Circulation: Journal of the American...


Word of the Day
snash
  • To talk saucily.
  • Insolent, opprobrious language; impertinent abuse.
This word is Scots in origin and probably imitative.