Avandia, generic rosiglitazone maleate, is a drug to treat Type 2 diabetes and is manufactured by the UK-based pharmaceutical giant GlaxoSmithKline. Type 2 diabetes is the most common form of diabetes, affecting about 18 million Americans.
In Type 2 diabetes the body either does not produce enough insulin or does not use insulin properly. This results is high blood sugar levels that can cause problems such as kidney and eye damage. The Avandia claim is that it lowers blood sugar levels by increasing the sensitivity to insulin in peripheral tissue.
1 Million Americans have taken Avandia
Avandia was the top-selling diabetes drug in the world and the second best seller for GSK, after its asthma drug Advair. It’s estimated that Avandia was taken by 1 million Americans in 2006 and generated $3 billion in sales.
Avandia was approved by the FDA (Food and Drug Administration) on May 15, 1999 for the treatment of diabetes. There was some controversy about the approval, but the FDA may have wanted to expedite the approval since problems had already arisen with the other diabetes drug then on the market, Pfizer’s Rezulin. Rezulin was removed from the market in 2000 because it caused sometimes fatal liver problems.
Avandia is part of a class of drugs known as PPAR agonists. These drugs activate or suppress dozens of genes, causing complex biologic effects. The effects differ from one PPAR agonist to another, depending on the genes affected.
Avandia in the News
Avandia hit the headlines on May 21, 2007 when a meta-analysis of 42 studies on the use of Avandia showed a significant increase in the risk of heart attack and other heart problems.
The FDA eventually issued a warning about the study and required GSK to include a black box warning of cardiac side effects and to produce a new prescription guide that included these warnings. Critics claim the FDA should have acted sooner. The agency came under criticism and scrutiny for its handling of the Avandia approval and review.