8 December, 2011
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Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia Lawsuit | Avandia News | Avandia Recall | Avandia Safety | Avandia Senate Report | Avandia Settlements | Avandia Side Effects | Avandia Warning | Congestive Heart Failure19 November, 2010
Health Canada, the national drug regulatory agency, has put tight new restrictions on the use of Avandia (rosiglitazone), Avandamet (rosiglitazone and metformin) and Avandaryl (rosiglitazone and glimepiride).
To get a new Avandia prescription, diabetes patients will be required to sign an informed consent form confirming that they have read and understand consumer information about the drug’s heart-related risks and discussed with their physician other diabetes treatment options. In addition, A new boxed warning has been added to the package insert. Continue reading Canada puts new restrictions on diabetes drug Avandia
Category: Avandia Cardiovascular Risk | Avandia News | Avandia Side Effects | Avandia Warning | Congestive Heart Failure15 October, 2010
A FDA Avandia news conference was held on September 23, 2010 to announce the FDA decision on Avandia and for FDA drug safety officials to take questions from the media.
The following is a complete transcript of the news conference. FDA Commissioner Margaret Hamburg, FDA Principal Deputy Commissioner Joshua Sharfstein and Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA all were in attendance. Continue reading FDA Avandia news conference: 2010 rosiglitazone restrictions
Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Warning8 October, 2010
In May 2007, Cleveland Clinic cardiologist Dr. Steven Nissen published an Avandia study in the New England Journal of Medicine that would mark a turning point for the diabetes drug Avandia.
Dr. Nissen found that Avandia use was linked to a 43% increased risk of heart attack. and has been a vocal critic of Avandia ever since. Dr. Nissen reacts to the September 23, 2010 FDA Avandia restrictions. Continue reading FDA Avandia heart attack news, Avandia critic reacts to FDA
Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Safety | Avandia Settlements | Avandia Warning13 July, 2010
Joint Meeting
Endocrinologic and Metabolic Drugs Advisory Committee
and
Drug Safety and Risk Management Advisory Committee
Hilton Washington DC North/Gaithersburg
July 13 – 14, 2010
Meeting Roster
A list of 47 experts at the joint FDA drug advisory committee meeting to evaluate Avandia safety data, cardiovascular/heart risk, side effects and an Avandia recall. Continue reading FDA Avandia Safety Joint Advisory Committee Meeting Roster - Experts
Category: Avandia FDA | Avandia Recall | Avandia Safety | Avandia Side Effects | Avandia Warning11 March, 2010
Avandia heart side effects lawsuits could cost GlaxoSmithKline up to $6 billion, said UBS analysts in a note made public last week.
The UBS note follows a highly critical report on the drug by the U.S. Senate Finance Committee. Over 13,000 Avandia personal injury and wrongful death lawsuits currently are pending against the GSK… Continue reading Avandia side effects lawsuit settlements could top $6 billion in liability for GSK
Category: Avandia Lawsuit | Avandia News | Avandia Senate Report | Avandia Settlements | Avandia Side Effects | Avandia Warning