GSKPresentation Guidelines and FDA Guidelines Fails to Follow

An individual was hired to conduct trials on the patients taking Avandia. According to Wall Street Journal and Food and Drug Administration, 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.”

According to the report, Manuel J. Quinones started the trial without getting approval from the International Review Board. Moreover, he did not keep the records of case histories of individual patients.

Avandia is used for the treatment of patients suffering from type 2 diabetes. It is manufactured by GlaxoSmithKline. It was introduced to the market on May 25, 1999. It belongs to the family of drugs called thiazolidinediones. Patients suffering from type 1 diabetes should not consume Avandia because it may cause following side effects:

• Increased chances of bone fracture
• Weight gain
• Headache
• Back pain
• Chances of cardiac arrest increases
• Cough
• Inflammation of sinuses
• Swelling
• Cold
• Fluid retention

Dangers of Taking Avandia

Patients who are dependent on Avandia have been recently issued warnings against the drug. For example, according to the study published by The New England Journal of Medicine, in 2007, revealed that patients consuming Avandia were 43 percent more risk of suffering from heart diseases.

The other study conducted by Swiss Researchers, determined that consumption of Avandia causes Osteoporosis among women. Researchers examined the medical records of more than 1000 diabetic patients suffering from bone fractures between the period of 1994 to 2005.

Patients who are suffering from Avandia side effects should consult their doctor immediately because they may have to discontinue the consumption of drug. He should also seek the advice of pharmaceutical attorney for filing lawsuit against company.