Timeline of Avandia Heart Side Effects
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The diabetes drug Avandia has been the center of controversy since reports linked the popular medication to an increased risk of heart attacks, heart failure and death.
The timeline outlined below provides a summary of the sequence of events leading to the discovery of information regarding heart problems associated with the popular diabetes drug since it was approved by the FDA.
The manufacturer of Avandia, GlaxoSmithKline, knew or should have known about the heart risks associated with their type 2 diabetes drug for some time, yet they failed to warn the public or the medical community. .
>>INFORMATION: Avandia Heart Risk Side Effects
AVANDIA TIME LINE
May 25, 1999 - FDA Avandia approval was given to allow GlaxoSmithKline (then SmithKline Beecham) to begin marketing rosiglitazone for treatment of Type 2 diabetes.
2000 - A leading diabetes expert, John Buse M.D., expressed concerns regarding potential Avandia heart risks. He subsequently reported that he was "intimidated" by the drug maker for speaking out about the dangers which could be associated with the diabetes medication
2001 - The FDA issued a reprimand letter to the drug maker after sales representatives made misleading statements which down played the heart risks. False and misleading comments were made to an undercover investigator at a medical conference.
2002 - Public Citizens Health Research Group criticized the FDA for failing to follow recommendations of their staff scientists to add a strong "black-box" warning to Avandia, and its rival Actos.
2005 - The drug manufacturer prepared a draft analysis of clinical data (the same data later reviewed by independent researchers in May 2007) which provided indication that there should be concerns about heart risks associated with Avandia.
2006 - The FDA announced an Avandia warning label change to indicate the drug potentially increases the risk of heart disease and heart-related pain. However, the warnings were not prominently displayed and did not adequately convey the risk of Avandia side effects.
May 2007 - A New England Journal of Medicine Avandia report was published which indicates that an independent review of the data submitted to the FDA in 2005 shows a 43% increase in the risk of heart attacks, and over 60% increase in the risk of cardiovascular death associated with use of Avandia.
June 1, 2007 - Market analysts indicate that the rate of prescriptions for Avandia fell by 25% since May 18, 2007 following public release of information about the Avandia heart risks. Avandia's market share for new prescriptions of oral anti-diabetes drugs fell from 10% to nearly zero amid concerns.
June 6, 2007 - Congressional hearings are held to evaluate when information about Avandia heart attack risks was available and why it was not disclosed to the public earlier.
June 2007 - Following public pressure surrounding the congressional hearings, an FDA Avandia black box warning is recommended to indicate an increased risk of heart failure.
July 30, 2007 - A special FDA advisory committee meeting was held to discuss Avandia safety concerns and what additional steps may be necessary to protect the public.
November 14, 2007 - The FDA announces a new "black box" warning about the Avandia heart attack risk, after narrowly voting against an Avandia recall.
December 3, 2007 - A study explains that Avandia side effects could also increase the risk of osteoporosis and bone fractures.
January 24, 2008 - Report released where FDA staff scientists estimated that approximately 83,000 Avandia heart attacks may have been caused since the drug came onto the market.
August 29, 2008 - Editorial published in the medical journal heart questions the justification for continuing to use the drug and calls for an Avandia Recall.
October 30, 2008 - Consumer group Public Citizen highlights the Avandia liver failure side effects in a petition filed with the FDA calling for a ban of the diabetes drug.
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AVANDIA LAWSUITS
The Avandia Lawyers at Saiontz & Kirk, P.A. are reviewing lawsuits for users who suffered a heart attack, heart failure or death. Potential claims are being reviewed nationwide. There are no fees or expenses unless a recovery is obtained.
