30 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 Recall28 April, 2010
GlaxoSmithKline Q1 profits beat analysts’ estimates as progress is made toward settlement of Avandia lawsuits.
Without specifically mentioning Avandia, the diabetes drug manufacturer stated that legal costs for the quarter increased by over $319 million due to “the progress we are making towards settlement of a number of existing cases.” Over 2,000 Avandia lawsuits have been filed against Glaxo following a 2007 New England Journal of Medicine article linking Avandia to an increased risk of heart attack. Continue reading Progress made toward Avandia lawsuit settlements, Glaxo Q1 profit over $2 billion
Category: Avandia Lawsuit | Avandia News | Avandia Settlements24 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 Report21 April, 2010
An Avandia safety study called the TIDE trial may be suspended by the FDA over Avandia heart attack risks.
Calls for an Avandia recall have been renewed over concerns that the diabetes drug increases heart risks. In February, a critical Senate report on Avandia was released following a two-year Senate Finance Committee investigation… Continue reading FDA may suspend Avandia safety study, could lead to Avandia recall
Category: Avandia Cardiovascular Risk | Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Senate Report16 April, 2010
Authors of articles with favorable opinions of Avandia’s safety received money from Glaxo, reports The New York Times.
The New York Times reports that an analysis of Avandia research finds a “slant in articles” on the safety of the diabetes drug:
A new analysis of reviews and articles about the controversial diabetes drug… Continue reading Scientists with positive opinion of Avandia safety were paid by Glaxo, reports New York Times
Category: Avandia Cardiovascular Risk | Avandia News | Avandia Safety23 March, 2010
FDA in Saudi Arabia suspends diabetes drug Avandia
Distribution of Avandia has been suspended for six months by the Saudi Food and Drug Authority (SFDA), linking use of the diabetes drug to adverse cardiovascular effects. A decision has not been made whether a permanent Avandia recall will follow.
“The S FDA Committee… Continue reading Avandia suspended from market by Saudi FDA
Category: Avandia Cardiovascular Risk | Avandia News | Avandia Recall | Avandia Safety | Avandia Side Effects23 March, 2010
Avandia research study shows experts defending the diabetes drug had financial ties to GlaxoSmithKline
They discovered that 94% of the authors who defended Avandia (rosiglitazone) had financial ties to drug makers. Almost half of the financial ties amounted to a conflict of interest… Continue reading Avandia heart attack risk researchers had financial ties to drug maker, conflicts of interest
Category: Avandia Cardiovascular Risk | Avandia News | Avandia Safety | Avandia Side Effects11 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 Warning6 March, 2010
Avandia drug company GlaxoSmithKline defends its popular diabetes drug in a 30-page “white paper” released February 24 rejecting a recent Senate Report stating that GSK downplayed the safety risks of their diabetes treatment Avandia. The prescription drug maker attacks the Senate Finance Committee’s January 2010 report on Avandia, claiming it is inaccurate, unbalanced and gives Continue reading Avandia maker GlaxoSmithKline releases "White Paper Response" to Senate Report on Avandia
Category: Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Senate Report23 February, 2010
The U.S. Food and Drug Administration is reviewing data on possible heart risks with GlaxoSmithKline diabetes drug Avandia but has not reached any new conclusions. The FDA will hold a public meeting in July 2010 to discuss the risks and benefits of the Avandia, but said in the meantime doctors and patients should continue to use Avandia Continue reading FDA: No new conclusions on Glaxo's Avandia yet
Category: Avandia Cardiovascular Risk | Avandia Lawsuit | Avandia News | Avandia Recall | Avandia Safety