Avandia Lawyers Fill FDA’s Gap

On August 26, 2010, the U.S. Food and Drug Administration (F.D.A.) issued a restriction on GlaxoSmithKline’s drug Avandia, or rosiglitazone.  Avandia, once a hugely popular drug used throughout the world in the treatment of patients with type 2 diabetics, has been critiqued almost as long as it has been legal.  Approved by the F.D.A. in the late 1990s, Avandia has been cited for serious health risks including heart attack, heart failure and, most recently, liver failure. Numerous studies, reports and petitions, in addition to an estimated 13,000 lawsuits pursued by St. Louis Avandia lawyers, have finally resulted in the federal restriction.  However, the prominent consumer advocacy group Public Citizen asserts that the lack of a complete ban on Avandia points to the F.D.A.’s subservience to corporate interests.  A federal ban on Avandia, such as was issued in the European Union (also on August 26, 2010), would no doubt further the efforts of Avandia lawyers to hold G.S.K. accountable for thousands of cases of wrongful death and personal injury, but could also potentially save many lives in the future.  Therefore the question must be asked: Why has the F.D.A. neglected to issue a full ban?

Successful St. Louis Avandia lawyers have reached settlements in at least 11,500 Avandia lawsuits by showing that the corporation (G.S.K) withheld evidence showing Avandia’s connection to heart disease and heart attack.  Three studies released in 2007 – one published in the New England Journal of Medicine, another released by G.S.K. which was actually conducted in 2004, and a third conducted by the F.D.A. – all indicated that Avandia raised the risk of myocardial ischemia (heart disease) in patients.  No clear evidence of heart failure was presented through those studies, which were only conducted over the short-term and therefore could not be hoped to detect serious side effects that result from long-term use.  Clear indication of heart disease should have led G.S.K. and the F.D.A. to further research the health risks at the time.  Instead, a long-term study conducted by independent researchers was published in the Journal of the American Medical Association (JAMA) showing Avandia’s potential to increase the risk of heart attack. 

In 2005 and 2006, G.S.K also conducted a meta-analysis of existing studies of Avandia and found that the drug caused an increase in the risk of heart problems by one-third.  G.S.K.’s delay in releasing the outcomes of the 2004 study and the 2005-2006 meta-analysis, combined with the Senate Finance Committee’s full review of 250,000 internal company documents, revelas that the company was remiss to the release of vital information that linked Avandia to serious health risks as early as 2003, meanwhile continuing to market the drug internationally.

St. Louis Avandia lawyers and others also allege that G.S.K. suppressed critical remarks made of Avandia.  In one example, a professor at the medical school at the University of North Carolina, Dr. John Buse, was threatened by the company when he made public comments about his suspicions of Avandia’s health risks.  He later formally agreed not to share his worries about Avandia in public settings.  

Despite evidence that G.S.K. was aware of  and suppressed Avandia’s severe health risks for the better part of a decade, the G.S.K. drug is still legal in the U.S. market.   This reality calls into question the effectiveness of the F.D.A.’s regulatory arm.  Due to its failure to protect U.S. consumers from profit-seeking corporation, the F.D.A. should be examined for possible corruption.

Get Answers on Avandia

The FDA warning released about the serious health risks associated with Avandia has left patients confused, concerned and even in danger. Patients who terminate their use of the drug without the oversight of a physician may be taking even greater medical risks off the drug than on it, experts warn.

Manufactured by GlaxoSmithKline, Avandia is used to treat type 2 diabetics. It functions as an insulin sensitizer, boosting the body's ability to regulate glucose levels in the blood. Clinical studies and complaints filed to the FDA have revealed that the drug is likely to increase the risk of heart attack, heart failure and stroke in patients using the drug over the long-term. Affected individuals and their families have filed Avandia lawsuits for personal injury and wrongful death related to these health risks.

Reports of these claims have been met by widespread controversy. In fact, when the FDA released its September 2010 restriction on the drug, GlaxoSmithKline (the drug's manufacturer) responded with a 30-page rebuttal stating that the evidence cited by the FDA did not match the credibility of the extensive clinical trials conducted by the company. The FDA's restriction on the drug instructed that the drug was only to be administered in patients known to be free of the adverse health risks, patients who lack other means to effectively control their glucose levels and patients who have signed a release indicating they are aware of the potential health risks associated with the drug.

In the wake of so much controversy, and in light of a rash of consumers filing an Avandia lawsuit, type 2 diabetics are seeking clarity about the drug. Questions they are asking include: If I am already taking Avandia, should I continue taking it? Is there a way to know if it is truly safe for me? Are there other drugs on the market that serve the same purpose without the health risks associated with Avandia? What recourse can I take if I feel Avandia has harmed me?

If I am already taking Avandia, should I continue taking it? Is there a way to know if it is truly safe for me? Experts agree that until an alternative therapy is prescribed by a physician, patients currently taking Avandia should continue to use the drug. The risk of not regulating their glucose levels is more immediate and certain. If taking Avandia over the long term scares you, consult with your medical provider before ceasing use of the drug.

Are there other drugs on the market that serve the same purpose without the health risks associated with Avandia? Takeda Pharmaceutical's Actos is a drug in the same class as Avandia. While it may also increase the risk of congenital heart failure, it is not known to cause heart attack, angina or stroke.

What recourse can I take if I feel that Avandia has harmed me? The FDA requests that consumers file adverse drug reaction reports through the MedWatch program. You may also join the ranks of other diabetics filing Avandia lawsuits.