FDA panel OKs looser restrictions on Avandia
In a reversal of its past position, a majority of a 26-person Food and Drug Administration advisory panel voted to recommend looser restrictions on the controversial diabetes drug Avandia. (Source: CNN.com - Health)
Source: CNN.com - Health - June 6, 2013 Category: Consumer Health News Source Type: news
GSK statement in response to FDA Advisory Committee’s vote on availability of Avandia (rosiglitazone)
GlaxoSmithKline [NYSE: GSK] confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to continue to make Avandia (rosiglitazone) available to appropriate patients with the majority of the members voting to either modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program in place. Remaining members voted to continue the REMS (5) or withdraw (1) Avandia from the US market. (Source: GSK news)
Source: GSK news - June 6, 2013 Category: Pharmaceuticals Source Type: news
FDA panel votes to modify Avandia restrictions
WASHINGTON (Reuters) - U.S. health advisers voted on Thursday to recommend modifying market restrictions on GlaxoSmithKline's diabetes drug Avandia, the one-time blockbuster at the center of one of the biggest drug controversies in recent years. (Source: Reuters: Health)
Source: Reuters: Health - June 6, 2013 Category: Consumer Health News Tags: healthNews Source Type: news
FDA panel backs changes to Avandia safety rules
Advisory panel of experts told FDA that heart safety restrictions that have been on diabetes drug since 2010 should be modified (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - June 6, 2013 Category: Consumer Health News Source Type: news
Will Avandia Return? A Live Blog Of Today's FDA Advisory Committee
A panel of advisers to the Food and Drug Administration is deliberating whether to lift restrictions that have caused the diabetes drug Avandia, made by GlaxoSmithKline, to go from being the most-used diabetes pill to a product used by only 3,000 patients. They could also withdraw the drug, or leave things as they are. The reason for the the debate is a new analysis of an existing clinical trial that may indicate that Avandia does not raise the risk of death. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - June 6, 2013 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news
FDA Panel Votes to Change Tight Restrictions on Diabetes Drug Avandia
But critics say second look at controversial drug a waste of time (Source: WebMD Health)
Source: WebMD Health - June 6, 2013 Category: Consumer Health News Source Type: news
FDA says again: Rosiglitazone does not up CV risk
The first day of a two-day meeting on rosiglitazone included presentations from the FDA, GlaxoSmithKline, Duke University reviewers, and one dissenting FDA official. Today the panel will vote on the drug's future. (Source: theHeart.org)
Source: theHeart.org - June 6, 2013 Category: Cardiology Source Type: news
FDA on RECORD Readjudication: Avandia Does Not Up CV RiskFDA on RECORD Readjudication: Avandia Does Not Up CV Risk
The first day of a 2-day meeting on rosiglitazone included presentations from FDA, GlaxoSmithKline, Duke University reviewers, and 1 dissenting FDA official. Today the panel will vote on the drug's future. Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 6, 2013 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news
Avandia: Even if FDA reverses restrictions, will diabetes drug make a comeback?
Expert says "flawed" data a likely sticking point for docs in prescribing ex-top-selling diabetes drug; only 3,000 people still take drug in U.S. (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - June 6, 2013 Category: Consumer Health News Source Type: news
Video: Avandia: FDA may reverse restrictions
Once the top-selling diabetes pill in the world, Avandia was severely restricted by the FDA after reports that taking the drug could raise the risk of heart attack. But now, the agency may reverse those restrictions. Dr. Jon LaPook discusses the potential move and what it could mean for diabetes sufferers. (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - June 6, 2013 Category: Consumer Health News Source Type: news
FDA Mulls Lifting Tight Safety Limits on Diabetes Drug Avandia
Title: FDA Mulls Lifting Tight Safety Limits on Diabetes Drug AvandiaCategory: Health NewsCreated: 6/6/2013 10:35:00 AMLast Editorial Review: 6/6/2013 12:00:00 AM (Source: MedicineNet Diabetes General)
Source: MedicineNet Diabetes General - June 6, 2013 Category: Endocrinology Source Type: news
FDA Advisers Vote to Modify Restrictions on Avandia
(Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - June 6, 2013 Category: Primary Care Tags: Medical News Source Type: news
FDA Panel Starts to Tackle Avandia Safety
(MedPage Today) -- SILVER SPRING, Md. -- A controversial study of the cardiovascular safety of one-time diabetes blockbuster rosiglitazone (Avandia) has proven difficult for FDA and independent reviewers to reanalyze, multiple speakers said here Wednesday. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - June 6, 2013 Category: Cardiology Source Type: news
FDA Avandia Panel: A Twitter-Based Review
An FDA advisory panel is currently meeting to analyst a re-analysis of a clinical trial of the GlaxoSmithKline drug Avandia. For a summary of why this is important, read my piece from last night. This is a summary of what happened, culled from my tweets and those of others.
#FDA's Parks says RECORD like verb, such as "Remember to recórd the show, rather than noun: I'll keep a récord of that request #Avandia $GSK (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - June 5, 2013 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news
What Can The RECORD Trial Really Tell Us?
The FDA advisory panel examining the rosiglitazone (Avandia) RECORD trial is just about to complete the morning session of the first day. Here's a key exchange between panelist Sanjay Kaul and Duke's Ken Mahaffey, the principal investigator of the Duke re-adjudication of the trial. (This is a slightly edited version of the FDA running transcription.)
Kaul: Dr. Mahaffey, ...do you believe that the RECORD study allows an assessment of cardiovascular safety of rosaglitazone? (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - June 5, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
