FDA panel revisits Avandia, likely too late for diabetes drug
WASHINGTON (Reuters) - A U.S. Food and Drug Administration panel of outside experts reopened one of the biggest drug controversies in recent years on Wednesday at a meeting where they will decide whether to recommend lifting marketing restrictions on GlaxoSmithKline Plc's Avandia diabetes drug. (Source: Reuters: Health)
Source: Reuters: Health - June 5, 2013 Category: Consumer Health News Tags: healthNews Source Type: news
FDA panel revisits Avandia; likely too late for diabetes drug
(Reuters) - A panel of medical advisers to the U.S. Food and Drug Administration will revive a six-year-old debate over the safety of GlaxoSmithKline Plc's Avandia diabetes drug, but the two-day meeting that starts on Wednesday is not expected to greatly boost sales of the onetime blockbuster product. (Source: Reuters: Health)
Source: Reuters: Health - June 5, 2013 Category: Consumer Health News Tags: healthNews Source Type: news
Battleground FDA: How Tomorrow's Avandia Panel Could Help Shape The Future Of Diabetes
Avandia, once the best-selling diabetes pill on the planet, is now given only to a few thousand Americans. In much of the rest of the world it has been pulled from the market because of analyses that showed it might increase the risk of heart attacks. The controversy over the drug changed the way the Food and Drug Administration regulates diabetes medicines, resulting in steep requirements that new drugs prove they are unlikely to cause heart side effects. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - June 4, 2013 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news
FDA Reconsiders Curbs on Avandia
FDA documents suggest the agency is considering reviving a drug that has been highly restricted for nearly three years—the Glaxo diabetes pill Avandia—and restoring it to full marketing status in the U.S. (Source: WSJ.com: Health)
Source: WSJ.com: Health - June 3, 2013 Category: Pharmaceuticals Tags: PAID Source Type: news
FDA Gives Avandia Another Look
(MedPage Today) -- A reassessment of the results of the RECORD trial by independent reviewers has turned up similar results to the initial report, possibly signaling new life for the embattled diabetes drug rosiglitazone (Avandia), according to FDA documents. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - June 3, 2013 Category: Cardiology Source Type: news
FDA review: Avandia may not be as risky for heart as once thought
Avandia was top-selling diabetes pill in the world by 2006, until use was severely restricted in 2010 over heart risks (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - June 3, 2013 Category: Consumer Health News Source Type: news
F.D.A. Experts Find No Misconduct in Avandia Tests
As an F.D.A. advisory panel revisits the debate around the diabetes drug Avandia, a report by staff experts found no fraud in its clinical trial. (Source: NYT Health)
Source: NYT Health - June 3, 2013 Category: Consumer Health News Authors: By KATIE THOMAS Tags: Clinical Trials Drugs (Pharmaceuticals) Avandia (Drug) Food and Drug Administration GlaxoSmithKline PLC GSK NYSE Source Type: news
F.D.A. Scientists Find No Serious Misconduct in Avandia Tests
As an F.D.A. advisory panel revisits the debate around the diabetes drug Avandia, a report by staff scientists has found no fraud in its clinical trial. (Source: NYT Health)
Source: NYT Health - June 3, 2013 Category: Consumer Health News Authors: By KATIE THOMAS Tags: Clinical Trials Drugs (Pharmaceuticals) Avandia (Drug) Food and Drug Administration GlaxoSmithKline PLC GSK NYSE Source Type: news
Second Thoughts on Safety of Avandia Stir a Dispute
In a highly unusual move, the agency has decided to reopen the case on Avandia and will ask a committee whether it should reconsider the restrictions on the drug. (Source: NYT Health)
Source: NYT Health - June 2, 2013 Category: Consumer Health News Authors: By KATIE THOMAS and SABRINA TAVERNISE Tags: Heart Drugs (Pharmaceuticals) Avandia (Drug) Food and Drug Administration Merck & Company Inc MRK NYSE Diabetes GlaxoSmithKline PLC GSK NYSE Source Type: news
What if Avandia Is Safe After All?What if Avandia Is Safe After All?
A much-maligned diabetes drug may get a shot at vindication at an upcoming hearing of the US Food and Drug Administration. Medscape Diabetes & Endocrinology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 31, 2013 Category: Consumer Health News Tags: Diabetes & Endocrinology Expert Column Source Type: news
Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone
An independent re-adjudication of the RECORD trial has confirmed the original findings of the trial, that rosiglitazone d0es not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - May 29, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial FDA Meeting
Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - May 24, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
Certain statins can raise risk of developing diabetes
Overall benefits of statins outweigh risks, say expertsRelated items from OnMedicaRegulators suspend Avandia over safety concernsIgnored cholesterol blamed for heart attacksPolypill could halve cardiovascular events Hospitals fail women with myocardial infarctionStatins halve heart attack and stroke risk in healthy adults (Source: OnMedica Latest News)
Source: OnMedica Latest News - May 24, 2013 Category: UK Health Source Type: news
Glaxo Alleges Errors In Nissen's Critique Of FDA's Handling Of Avandia
This morning, I published a guest post from Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, alleging that the most likely rationale for an upcoming panel meeting being held by the Food and Drug Administration was to make some FDA leaders less accountable for the scandals that surrounded the diabetes drug Avandia. (See:The Hidden Agenda Behind The FDA’s Avandia Hearings.) This is the GlaxoSmithKline's prepared statement in response to that article. The FDA's response can be found here. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - May 24, 2013 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news
The FDA Responds To Steve Nissen's Criticism Of Upcoming Avandia Meeting
This morning, I published a guest post from Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, alleging that the most likely rationale for an upcoming panel meeting being held by the Food and Drug Administration was to make some FDA leaders less accountable for the scandals that surrounded the diabetes drug Avandia. (See: The Hidden Agenda Behind The FDA's Avandia Hearings.) This is the FDA's response to that post, sent via its press office. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - May 23, 2013 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news
