Avandia Lawyer, Avandia Attorney
Avandia is manufactured by GlaxoSmithKline, a British pharmaceutical company. Typically, Avandia is prescribed to patients who suffer from Type 2 diabetes, a condition in which the body does not use insulin normally and cannot control the amount of sugar in the blood. Avandia is also known by the name Rosiglitazone. Avandia has been linked to an increased risk of heart attacks, strokes and Congestive heart failure.
In 1999, Food and Drug Administration (FDA) approved the sale of Avandia. It is marketed as an oral anti-diabetic agent that increases the insensitivity of insulin. It is estimated that about one million patients in America take Avandia to combat Type 2 diabetes.
Problems with Avandia
As early as 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
Then in 2001, the FDA issued a reprimand letter to GSK because sales representatives were making misleading statements which down played the heart risks. False and misleading comments were made to an undercover investigator at a medical conference.
In 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.
The FDA announced in 2006 a change in the warning label for Avandia 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.
In 2007, clinical studies conducted indicated Avandia had caused some patients to suffer from Avandia injuries such as a heart attacks, strokes and congestive heart failure. It was determined there was a 43 percent increased risk for a heart attack for those using Avandia, according to this study. Some other patients reported suffering from other types of Avandia injuries such as heart failure, low blood sugar, liver problems, fractures, and weight gain. This prompted the FDA to issue an alert concerning Avandia injury. They determined that Avandia was associated with a greater risk for heart attack rather than the use of a placebo.
A follow up study, in 2008, which studied 10,000 patients (The ACCORD clinical trial involving diabetes treatment) was halted 18 months early due to increased risk of patients death. The clinical trial was stopped after the Data Safety and Monitoring Board found that the rigorous treatment increased the patients’ risk of death by 25%. The results brought into question the methods used to lower blood sugar.
Avandia was recently back in the news, when it was found that Dr Steven Haffner, admitted leaking information about a study linking the drug to a 43% greater risk of heart attacks to GlaxoSmithKline PLC 17 days before the article was published in the New England Journal of Medicine, last May.
