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Avandia in the News - Defective Drug Lawyers

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he diabetes drug rosiglitazone, marketed as Avandia by manufacturer GlaxoSmithKline, has been the subject of controversy for several years now because of potentially dangerous and deadly side effects. The US Food and Drug Administration (FDA) along with international pharmaceutical regulatory bodies such as the European Medicines Agency and Britain's Medicines and Healthcare Products Regulatory Agency (MHRA) have been looking into Avandia since a 2007 study showed an increased risk of heart attack for Avandia patients.

FDA Restricts Avandia Use

In a rare joint statement with the European Medicines Agency, the FDA yesterday announced severe new restrictions on Avandia in the US, including Oklahoma. Avandia will be pulled completely from the market in Europe.

Increased publicity of the risks of Avandia, especially heart disease and heart attacks, may lead to an increase in Avandia defective drug lawsuits as more patients come forward to sue for defective drug injuries and wrongful death. As of July 13, 2010 Reuters reported that GlaxoSmithKline had agreed to pay $460 million in Avandia settlements to about 10,000 plaintiffs.

In addition, the FDA's decision to restrict Avandia may make judges and juries more likely to believe plaintiff claims of defective drug injuries from Avandia, resulting in more Avandia settlements and possibly millions more dollars in defective drug injury compensation.

Avandia in the News

The controversy over scientific evidence and regulatory decisions about Avandia has been ongoing for years, heating up this year as more and more evidence has pointed to Avandia prescription drug injuries. Below is a timeline of important events leading up to the September 23, 2010 FDA decision on Avandia:

  • May 2007 – Study by Dr. Steven Nissen of the Cleveland Clinic claims patients taking Avandia are 43% more likely to have a heart attack.
  • July 2007 – FDA panel votes not to recall Avandia, saying evidence of heart attack risk not conclusive enough for drastic measures.
  • November 2007 – FDA requires labeling of Avandia that states "inconclusive" evidence of increased heart attack risk.
  • February 2010 – Senate Finance Committee issues report saying GlaxoSmithKline was fully aware of Avandia’s heart risks as early as late 2004 or early 2005.
  • June 2010 – Dr. David Graham, an FDA scientist, estimates Avandia has caused up to 100,000 cases of heart attack, stroke, heart failure, and death. Dr. Graham strongly argues for the FDA to recall Avandia.
  • July 2010 – FDA expert panel votes to keep Avandia on the market by a 20-12 margin. Half of experts voting to keep Avandia available say it should be limited.
  • July 2010 – Reports surface showing members of the FDA panel that kept Avandia on the market may have had improper financial relationships with GlaxoSmithKline, raising questions of conflicts of interest in Avandia panels.
  • September 2010 – FDA investigates safety of Avandia after study links very similar competitor drug Actos to increased risk of bladder cancer.
  • September 23, 2010 – FDA announces severe restrictions on patients who can receive Avandia; European Medicines Agency completely removes Avandia from European market.

Millions in Compensation for Prescription Drug Injuries

According to a July 15, 2010 online press release by GlaxoSmithKline, maker of Avandia and other potentially dangerous prescription drugs, GSK estimated paying about $2.36 million in defective drug lawsuit settlements, agreements to settle, and other legal expenses in the second quarter of 2010 alone.

These expenses are related not only to Avandia, but also to other problematic prescription drug injury lawsuits, such as Paxil drug injury lawsuits.

If you or a family member has had a heart attack, stroke, or experienced another negative medical event after taking Avandia, please contact the Oklahoma drug injury attorneys of Stipe Law Legal Group today to discuss your legal options.

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