14 July, 2010
On July 14, 2010, the joint FDA drug advisory panel on Avandia safety voted NOT to recall Avandia, GlaxoSmithKline’s controversial Type 2 Diabetes medicine.
How did the 33 members of the FDA advisory committee vote when asked what regulatory action should be taken on Avandia by the U.S. Food and Drug Administration? Here are the number of votes received for each of the options: Continue reading FDA Panel Vote NO AVANDIA RECALL, Revise Warning, Restrict Use
Category: Avandia FDA | Avandia News | Avandia Recall13 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 Warning8 July, 2010
The FDA’s staff report on Avandia safety and all supporting data will be made public tomorrow. An Avandia recall may not be far behind
A report on Avandia safety risks is expected to be released tomorrow by the Food and Drug Administration. The future of the diabetes drug hangs in the balance. Critics claim Avandia heart risks outweigh its benefits and long have demanded an Avandia recall. Several scientific studies, including two released last week, have linked the drug to higher heart risks than other diabetes drugs. Continue reading Avandia safety risks FDA staff report, data to be released July 9, 2010
Category: Avandia FDA | Avandia News | Avandia Recall | Avandia Safety1 July, 2010
Three new studies about Avandia side effects and heart risks were released this week. Two link the diabetes drug to an increased risk of heart attack, stroke or heart failure. The third suggests that taking Avandia may be associated with a lower risk of heart attack, stroke or death than not taking Avandia or Actos, its rival TZD. As the July FDA drug safety meeting approaches and Avandia lawsuit settlements are reported, demands for an Avandia recall are intensifying. Continue reading Cardiac researcher predicts new heart risks warning, but no Avandia recall by FDA
Category: Avandia Cardiovascular Risk | Avandia News | Avandia Recall | Avandia Safety29 May, 2010
The trial Saudi FDA recall of Avandia is questioned while Avandia lawsuit settlements are reached in the U.S..
Despite growing evidence of the cardiovascular risks associated with Avandia, a leading Saudi diabetes doctor would like to its FDA recall reversed. Meanwhile, the first round Avandia lawsuit settlements have been reported in the U.S.. Continue reading Saudi FDA recall of Avandia is questioned while Avandia lawsuit settlements are reached in U.S.
Category: Avandia Lawsuit | Avandia News | Avandia Recall | Avandia Settlements12 May, 2010
Avandia lawsuit settlements have been reached in hundreds of cases. Glaxo will pay millions but the exact settlement amounts are being kept confidential.
Glaxo has settled nearly 700 of the lawsuits filed by people harmed by Avandia. Most of the settled cases are for people who had heart attacks after taking the diabetes drug. Other injuries include stroke and congestive heart failure. Many are wrongful death claims. Continue reading Settlements reached in hundreds of Avandia lawsuits, settlement amounts confidential
Category: Avandia Recall | Avandia Settlements8 May, 2010
Glaxo will defend Avandia at a July FDA meeting from calls for a recall. The drug company faces over 2,000 Avandia lawsuits filed after a 2007 study linked heart attack and congestive heart failure to Avandia use. Continue reading Avandia drugmaker will continue to defend drug from lawsuits and recall, says Glaxo CEO
Category: Avandia News | Avandia Recall2 May, 2010
In testimony to Congress, consumer group demands Avandia recall and halt to the TIDE drug safety trial
Dr. Sidney Wolfe, Director of the Health Research Group at the non-profit consumer advocacy group Public Citizen, testified that the health and safety of thousands of innocent people are being jeopardized by allowing the TIDE trial to continue. Continue reading Leading drug safety expert to Congress: Recall Avandia and stop TIDE trial
Category: Avandia FDA | Avandia News | Avandia Recall | Avandia Safety30 April, 2010
Heart side effects concerns and the possible recall of Avandia have led to a significant drop in sales of the popular diabetes drug.
Despite earnings and revenue being up 9% and 17%, respectively, a possible FDA Avandia recall leads financial analysts describe Glaxo’s first-quarter report as “gloomy.” Continue reading Avandia recall threat takes financial toll on GlaxoSmithKline
Category: Avandia FDA | Avandia News | Avandia Recall24 April, 2010
Avandia safety assessment at July meeting of joint FDA committees to lead to TIDE Trial decision.
When the FDA convenes a joint meeting of its Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory committees in July, the agency will assess the cardiovascular safety of Avandia and decide whether the controversial TIDE… Continue reading Assessment of Avandia Safety at July FDA meeting to lead to TIDE Trial decision
Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Senate Report