Guidelines Not Followed With Avandia Manufacturering
News agency finds mistakes during an Avandia clinical trial made by an individual hired to conduct the trials during a six-year period.
According to reports from both the U.S. Food and Drug Administration (FDA) and the Wall Street Journal, "Manuel J. Quinones of Redondo Beach, Calif., failed to ensure the trial had a safety board meant to protect the rights, welfare and safety of humans involved in the study."
Quinones allegedly began the trial without receiving approval from the International Review Board, an organization that acts as a safety net for human beings involved in clinical trials. The Wall Street Journal reported that Quinones did not have "adequate and accurate case histories of patients,".
What is Avandia?
Avandia is a type 2 diabetes drug manufactured by GlaxoSmithKline. It was first approved for market on May 25, 1999 and is part of a group of drugs known as thiazolidinediones, which are oral medications. Avandia (rosiglitazone) works by regulating an individual??s glucose levels and naturally providing more or less insulin within the body rather than requiring a patient to inject insulin into their body when levels become high or low. Avandia is not for individuals suffering from type 1 diabetes, and can potentially cause the following side effects:
* weight gain
* cough
* cold
* headache
* inflammation of the sinuses
* back pain
* swelling
* fluid retention
* increased incidence of bone fractures
* increased risk of cardiac arrest
Avandia Dangers
Patients who consume Avandia have recently been confronted with a number of warnings regarding the drug??s safety and potential harmful side effects. For example, a study in The New England Journal of Medicine from 2007, found that individuals who were consuming Avandia were 43 percent more likely to suffer from a heart attack than individuals who did not consume the drug.
A Swiss study also found a link between the drug's consumption and the development of osteoporosis, most common among women patients. The study utilized medical records from approximately 1,000 diabetic patients who may have been diagnosed with bone fractures during the time period of 1994 and 2005. According to the recors, those who consumed the drug were more likely to suffer from osteoporosis.
It is important for Avandia patients to discuss the use of the drug with their doctor. Additionally, it may be necessary for an Avandia patient to contact a pharmaceutical attorney regarding the development of an Avandia class action lawsuit. Because of the severity of the Avandia risks, a patient of the drug may have the potential to develop an Avandia lawsuit, which could result in monetary compensation.
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