Wall Street Journal Reports FDA and GlaxoSmithKline Did Not Follow Guidelines For Avandia

The Wall Street Journal recently uncovered a series of mistakes made by an individual who was hired to conduct clinical trials from 2000 to 2006 for patients receiving Avandia, the type 2 diabetes drug. 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. Additionally, Quinones allegedly did not keep "adequate and accurate case histories of patients," according to the Wall Street Journal.

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.

Additionally, a study from Swiss researchers recently uncovered a strong link between the consumption of Avandia and the onset of osteoporosis among patients, especially women. 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. The records allegedly showed that individuals were more likely to suffer from bone fractures caused by the onset of osteoporosis while consuming Avandia.

Patients who have consumed Avandia are urged to discuss the medication with their physician and may require the discontinuation of the drug. Additionally, it may be necessary for an Avandia patient to contact a pharmaceutical attorney regarding the development of an Avandia class action lawsuit. Development of such a lawsuit could result in monetary compensation for an individual who has suffered from the dangerous Avandia side effects.