AVANDIA – FDA Scrutinizes Diabetes Medication

 

In response to a May 21, 2007 article in the New England Journal of Medicine, The U.S. Food and Drug Administration has issued its strictest warning regarding the health risks associated with the use of a diabetes medication called Avandia.  The May 2007 article in the New England Journal of Medicine reported that users of Avandia faced a 43 percent higher risk of a heart attack or other cardiovascular problems than subjects given a placebo drug.

Avandia is used to control diabetes by increasing the body’s sensitivity to insulin.  It was approved in 1999 by the FDA and was considered to be a safe alternative to Rezulin, a drug that was banned by the FDA in 2000 under suspicion that is caused liver damage.

Avandia may now be facing the same fate.  Since the article’s release, the drug which became the world’s top selling diabetes treatment in 2006, generating annual revenue of $3.3 billion, is under intense scrutiny.  In addition to issuing a “black box” warning regarding the use of Avandia, the FDA has required the drug maker to strengthen labels, to warn patients using Avandia to watch for fluid accumulation in the legs, ankles and lungs, all of which increase the likelihood of heart problems.  The FDA has also requested, GlaxoSmithKline plc., to consent to a new trial of Avandia to compare the drug to similar diabetes medications.

If you or a loved one are suffering side effects from Avandia, please contact us for a free evaluation of your legal rights by clicking here.