22 July, 2010
While Avandia side effects data are being reviewed by the FDA, Avandia lawsuit settlements are being reached, and an Avandia recall still is being considered, the FDA has barred new diabetes patients from participating in the TIDE trial. Continue reading FDA Avandia news on TIDE: New patients barred
Category: Avandia FDA | Avandia News | Avandia Recall | Avandia Safety | Avandia Side Effects13 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 July, 2010
Advisory Committee Briefing Document: Cardiovascular Safety of Rosiglitazone
Prepared by GlaxoSmithKline for the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee
Meeting on July 13-14, 2010 Continue reading FDA Advisory Committee Briefing Document: Cardiovascular Safety of Avandia
8 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 Safety20 June, 2010
German drug watchdog group recommends Avandia insurance reimbursement ban.
The Federal Joint Committee of doctors and health insurers in Germany has not waited until next month’s FDA joint committee on drug safety to tell health insurance companies to stop paying for Avandia. Continue reading Avandia ban recommended by doctors and insurers in Germany
Category: Avandia News | Avandia Safety13 June, 2010
From: Graham, David J [mailto:David.Graham1@fda.hhs.gov]
Sent: Friday, May 28, 2010 3:31 PM
To: Hamburg, Margaret; Sharfstein, JM
Cc: Graham, David J
Subject: TZD study update
Dear Drs. Hamburg and Sharfstein,
Except for a few minor details, we have completed our study comparing the cardiovascular risks of rosiglitazone vs. pioglitazone in Medicare elderly. Continue reading Avandia study blocked: Dr. David Graham's email to FDA Com. Margaret Hamburg
Category: Avandia FDA | Avandia News | Avandia Safety13 June, 2010
The FDA denies suppressing a new study showing that Avandia use increases cardiovascular risks compared to Actos.
A recent study comparing the cardiovascular risks of rival Type 2 diabetes drugs has shown Actos to be safer than Avandia. The study, conducted by government scientists, found that Avandia increased the risk of heart attack, stroke, heart failure and death. Continue reading New study shows Avandia increases heart risks, FDA blocks publication
Category: Avandia Cardiovascular Risk | Avandia News | Avandia Safety8 June, 2010
Amid lawsuit settlements and calls for a recall, researchers claims low-dose Avandia may be safe.
A new study suggests that combination therapy using a low dose of Avandia may help prevent type 2 diabetes without increasing the risk of heart attack and death. Continue reading New study claims low-dose therapy may be safe as Avandia lawsuit settlements announced
Category: Avandia Cardiovascular Risk | Avandia News | Avandia Safety | Avandia Settlements20 May, 2010
GSK is having serious problems recruiting volunteers to participate in a large clinical trial of Avandia.
Two sites in the U.S. recently have withdrawn from the study due to poor enrollment. Several previous studies have linked the diabetes drug to an increased risk of heart attack. In response, Glaxo opened dozens of new Avandia trial sites last month outside the U.S. in developing nations, where participants may not be aware of the safety questions surrounding the diabetes drug. Continue reading Avandia trial: Glaxo having problems recruiting patient volunteers
Category: Avandia Cardiovascular Risk | Avandia News | Avandia Safety