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Avandia is a drug developed by GlaxoSmithKline for people suffering from type 2 diabetes mellitus. Type 2 diabetes is also referred to as “adult-onset” diabetes and “non-insulin dependent” diabetes. It is caused when a person’s body does not make enough insulin, or when their body cannot respond appropriately to its insulin production.

Although Avandia has proven to be an effective mode of treatment of people suffering from type 2 diabetes , it has also been linked with some serious side effects. Recent studies have linked Avandia with serious cardiovascular problems including heart attack and cardiovascular death. Women taking Avandia may face an increased risk of bone fracture.

 
In 2001 GlaxoSmithKline, the makers of the diabetes medicine Avandia received a warning letter from the U.S. Food and Drug Administration. The letter urged the company to be clear in its warnings about possible risks associated with taking Avandia, such risks include Avandia-induced heart attacks, Avandia-related cardiac disease and congestive heart failure caused by Avandia.

The combination of Avandia and insulin can result in a condition called fluid-overload disease, which may lead to cardiac arrest
and death.

Two Diabetes Drugs to Display Strongest Warning
The Food and Drug Administration is calling for the makers of Avandia and Actos to carry the most prominent safety warning to alert doctors and patients of potential heart risks. The call for a stronger warning comes more than a year after FDA safety reviewers recommended such steps. The agency made the announcement as officials were questioned as part of a Congressional investigation regarding the delayed warning of heart risks associated with Avandia.  Gardiner Harris, The New York Times  06/07/2007    Read Article: The New York Times

Drug Maker Threatened Lawsuit against Critic, A medical expert told lawmakers Wednesday that GlaxoSmithKline executives threatened him with a lawsuit after he drew attention to potential dangers of Avandia in 1999. John Buse, head of endocrinology at the University of North Carolina, told members of Congress that after he raised concerns about potential heart problems associated with Avandia, executives said they intended to hold him responsible for a $4 billion drop in company stock.  Matthew Perrone, Forbes  06/06/2007

Avandia Maker Sued Over Heart Attack

“The widow and son of a Beaumont man are suing the maker of the popular diabetes drug Avandia, alleging it contributed to the man's death from a heart attack. Larry Alan Stanford, 60, died May 21, the same day a scientific analysis was published in the New England Journal of Medicine saying that Avandia was linked to a greater risk of heart attack and possibly death. His widow, Peggie Stanford, and son, Ryan Stanford, filed the lawsuit against GlaxoSmithKline PLC on Tuesday in U.S. District Court for the Eastern District of Texas.”

Associated Press, Forbes 6/20/07

Diabetes Drugs to Receive Strongest Warning

The makers of diabetes drugs Avandia and Actos have agreed to add the most severe warning to inform patients that the medications may increase the risk of heart failure. The Food and Drug Administration said the so called “black box” warnings are separate from concerns that Avandia may increase the risk of heart attacks. A separate FDA review of Avandia and Actos side effects showed cases of significant weight gain and build up of fluids, both risk factors for heat failure.  AP, The Washington Post  08/16/2007


Experts called study done by Avandia inconclusive at best and a sign of greater risk at worst... read more.

 

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