Avandia Recall Lawyers: Senate Report Backs Up Calls to Recall Avandia
A new Senate report says that GlaxoSmithKline was well aware of the potential heart side effects of Avandia, yet failed to take steps to warn doctors or protect the public. In a 342-page report from the Senate Finance Committee, congressional investigators blast the drug maker and back up nearly three years of calls for regulators to issue an Avandia recall.
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The Avandia lawyers at Saiontz & Kirk, P.A. have been representing individuals who suffered a heart attack or other injury from Avandia since May 2007, when the first study was published in the New England Journal of Medicine about the risk of problems with Avandia. The Senate report echos allegations raised in hundreds of Avandia lawsuits filed against GlaxoSmithKline.
According to the Executive Summary of the Senate report:
[T]he reviewed evidence suggests that GSK (GlaxoSmithKline) knew for several years prior to this (May 2007) study that there were possible cardiac risks associated with Avandia. As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cadiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.
The Senate report links Avandia to more than 300 deaths in the third quarter of 2009, and estimates that every month about 500 heart attacks and 300 cases of heart failure could be avoided if diabetes patients were given Actos instead of Avandia.
On this blog, our lawyers have been posting for nearly three years about the dangers of Avandia and the overwhelming information that supports removing Avandia from the market:
- Following publication of the May 2007 study, which indicated Avandia side effects may increase the risk of heart attacks 43%, the FDA held advisory panel meetings in July 2007 to review whether a recall of Avandia was necessary. Although the panel voted 20 to 3 that the diabetes drug does increase the risk of heart attacks, they did not recommend a recall based on the evidence available at that time.
- In October 2007, an internal FDA board narrowly voted against an Avandia recall, with the drug-safety over-sight board voting 8 to 7 against removing the diabetes drug from the market.
- In November 2007, the European Association for the Study of Diabetes and American Diabetes Association updated their “consensus statement,” urging doctors to exercise greater caution when prescribing Avandia, pointing to the increased risk of heart attacks and heart failure.
- Although the FDA did not remove Avandia from the market, doctors took the issue into their own hands and stopped prescribing the dangerous diabetes drug in great numbers during the first year after the study was released. Amid concerns that Avandia increases the risk of heart problems, prescriptions plummeted between May 2007 and April 2008.
- In August 2008, an editorial published by the medical journal Heart questioned the logic for not recalling Avandia, indicating that the justification for continuing to use the drug was weak to non-existent.
- In October 2008, the prominent consumer advocacy group Public Citizen petitioned the FDA to recall Avandia, indicating that the risk of serious and potentially life-threatening side effects outweigh any potential benefits provided by the diabetes drug.
- In November 2008, another group of researchers, who presented data on a small study at the annual meeting of the American Heart Association, questioned the benefits provided by Avandia, indicating that it provided no statistically significant reduction in plaque buildup at 18 months when compared with an older generic diabetes drug.
- In December 2008, the FDA announced new guidance for approval of future diabetes drugs, requiring new medications go through additional studies designed to provide evidence that they will not increase the risk of heart attacks or other cardiovascular events. This raised the question of whether the Avandia heart attack risk would keep the drug from being approved today.
NOTE: No decisions about whether to stop taking a medication should be made without consulting your doctor.
AVANDIA RECALL LAWSUIT
The lawyers at Saiontz & Kirk, P.A. are continuing to review potential Avandia lawsuits for individuals who have suffered a:
- Heart Attack
- Heart Failure
- Liver Failure
- Bone Fracture
- Vision Loss or Blindness