Avandia's Future Still Bleak?
(MedPage Today) -- An FDA panel recommendation to loosen restrictions on the diabetes drug rosiglitazone (Avandia) isn't likely to affect how -- or whether -- doctors prescribe it, according to experts interviewed by MedPage Today. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - June 8, 2013 Category: Cardiology Source Type: news
Avandia (rosiglitazone) Does Not Raise Heart Attack Risk, Study
There is not a higher risk of heart attack and cardiovascular events in patients who take controversial type 2 drug Avandia (rosiglitazone), researchers at the Duke Clinical Research Institute (DCRI) reported after carrying out a re-analysis of data from a pivotal study. The DCRI researchers re-assessed the original findings of RECORD, a study that drew criticism from an 2010 FDA advisory panel. Yesterday, an FDA advisory panel recommended loosening the restrictions on Avandia... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 7, 2013 Category: Consumer Health News Tags: Diabetes Source Type: news
Restrictions On Avandia (Rosiglitazone) Should Be Loosened, Says FDA Panel
Most of the 26-member advisory FDA panel voted to loosen the restrictions which were placed on GSK's diabetes drug Avandia (rosiglitazone) in 2010 because of concerns it might raise the risk of heart attacks and death from cardiovascular causes. Seven panel members voted to remove all the restrictions, stating that the evidence for heart attack risk was not compelling, while five voted to leave the restrictions as they are. Thirteen voted to loosen the restrictions, e.g. not requiring patients to sign an informed consent form or to register... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 7, 2013 Category: Consumer Health News Tags: Regulatory Affairs / Drug Approvals Source Type: news
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 7, 2013 Category: Consumer Health News Source Type: news
Avandia Vote Ends An Era Of Drug Safety Scandals
Avandia, once the most-used diabetes pill on the planet, was all but finished. After concerns emerged that it might cause heart attacks, the Food and Drug Administration in 2010 put severe restrictions on Avandia, forcing doctors and patients to register and fill out paperwork to show they understood the risks. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - June 7, 2013 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news
Glaxo's Avandia Scores FDA Victory
A government panel called for easing restrictions on diabetes drug Avandia, in a remarkable about-face nearly three years after concerns over heart risk led regulators to curtail use of the drug. (Source: WSJ.com: Health)
Source: WSJ.com: Health - June 7, 2013 Category: Pharmaceuticals Tags: PAID Source Type: news
Rosiglitazone Restrictions Should Be Eased, FDA Panel SaysRosiglitazone Restrictions Should Be Eased, FDA Panel Says
Influenced by recent RECORD readjudication showing lack of significant harm, a joint FDA advisory panel votes to keep rosiglitazone on the US market and to ease current prescribing restrictions but not remove them entirely. Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 7, 2013 Category: Consumer Health News Tags: Diabetes & Endocrinology News Alert Source Type: news
FDA panel urges looser Avandia restrictions
In a reversal of its past position, a majority of a 26-person Food and Drug Administration advisory panel voted Thursday to recommend looser restrictions on the controversial diabetes drug Avandia. (Source: WDSU.com - Health)
Source: WDSU.com - Health - June 7, 2013 Category: Consumer Health News Source Type: news
Rosiglitazone restrictions should be eased, says FDA advisory panel
Influenced by a recent RECORD readjudication showing lack of significant harm, a joint FDA advisory panel voted to keep rosiglitazone on the US market and to ease current prescribing restrictions but not remove them entirely. (Source: theHeart.org)
Source: theHeart.org - June 7, 2013 Category: Cardiology Source Type: news
F.D.A. Advisers Vote to Relax Restrictions on Avandia
A Food and Drug Administration committee recommended that doctors have more freedom to use Avandia, a diabetes drug that in 2007 was linked to possible heart problems. (Source: NYT Health)
Source: NYT Health - June 6, 2013 Category: Consumer Health News Authors: By SABRINA TAVERNISE and KATIE THOMAS Tags: Heart Drugs (Pharmaceuticals) Avandia (Drug) Food and Drug Administration Diabetes GlaxoSmithKline PLC GSK NYSE Source Type: news
FDA votes to ease restrictions on GSK’s Avandia
The restrictions on prescribing and taking GlaxoSmithKline's controversial diabetes drug Avandia may be eased or removed after advisers to the US Food and Drug Administration found that the risk of cardiovascular events may be overstated. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - June 6, 2013 Category: Pharmaceuticals Source Type: news
FDA panel votes to relax Avandia restrictions
WASHINGTON (Reuters) - U.S. health advisers voted on Thursday to recommend relaxing market restrictions on GlaxoSmithKline's diabetes drug Avandia, the former 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 Loosens Noose on Avandia
(MedPage Today) -- SILVER SPRING, Md. -- A panel of FDA advisers thinks it is time to ease restrictions on access to Avandia (rosiglitazone), a onetime multimillion dollar blockbuster drug brought low by reports that it increased the risk of heart attacks. (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - June 6, 2013 Category: Geriatrics Source Type: news
FDA Panel Loosens Noose on Avandia
(MedPage Today) -- SILVER SPRING, Md. -- A panel of FDA advisers thinks it is time to ease restrictions on access to Avandia (rosiglitazone), a onetime multimillion dollar blockbuster drug brought low by reports that it increased the risk of heart attacks. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - June 6, 2013 Category: Cardiology Source Type: news
FDA Advisory Panel Backs Looser Restrictions On Avandia
After two days of deliberation an FDA advisory panel today recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - June 6, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
