Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2013 – “FDA lifts constraints on Glaxo diabetes drug Avandia”

Posted in Drug Studies, FDA Regulation

A recent article by Bill Berkrot and Ransdell Pierson (published in Reuters) reports on restrictions being lifted from the use of the drug Avandia.  Avandia is a diabetes drug made by the company GlaxoSmithKline that was thought to increase the risk for heart attacks for people using the drug.  The U.S. Food and Drug Administration conducted an investigation into the safety of the drug and found there was not a significant increase in risk for heart attacks with Avandia, and their recommendation led health regulators to lift the restrictions of use for the drug.

Type I diabetes is an autoimmune disease that inhibits the body from properly controlling the amount of sugar in the blood.  Type I diabetics do not produce insulin, which acts like a key that allows sugar to enter the cells.  Cells gain energy from sugar, and will die without the proper supply.  Type II diabetes can come as a result of a poor diet and lack of exercise that causes the pancreas to form defective insulin molecules that do not adequately perform their function.  Both types of diabetes are serious medical conditions that can be fatal if not properly handled.

A 2007 report that claimed Avandia was dangerous prompted a halting of the distribution of the drug from Europe, and resulted in restrictions on the sale of the drug in the US.  The chemical name of Avandia is rosiglitazone had been one of the best selling medications for Glaxo, earning the company billions of dollars before rumors of the drugs dangerous characteristics came about.  Despite the fact that recent studies have shown there is no increased risk for heart attack while using Avandia, it is still assumed the drug will only be prescribed to patients who have tried other diabetes medications without success.  Only a small fraction of Americans continue to take Avandia since the restrictions were put in place.