Avandia is a brand name for the drug rosiglitazone maleate. Made and sold by British pharmaceuticals giant GlaxoSmithKline Plc., this prescription medication is used to reduce the effects of Type 2 diabetes. It is sold as a stand-alone drug, but GlaxoSmithKline also sells it in combination with other anti-diabetic drugs. For example, when combined with metformin hydrochloride, it is sold as Avandamet, and when rosiglitazone is combined with glimepiride, GlaxoSmithKline markets it as Avandaryl.
GlaxoSmithKline received FDA approval to produce Avandia for sale in May 1999. The company began selling Avandia in tablet form in 2mg, 4mg, and 8mg doses. Avandamet (approved in 2002) contains 500mg or 1g of metformin hydrochloride, combined with 1mg, 2mg, or 4mg of rosiglitazone. Avandaryl (2005) contains 1mg, 2mg, or 4mg of glimeperide along with either 4mg or 8mg of rosiglitazone. Between 1999 and 2007, an estimated 6 million people used the drug for diabetes treatment.
Rosiglitazone (a thiazolidinedione) works as an insulin sensitizer by binding to peroxisome proliferator-activated receptors (PPARs) inside of cell nuclei, especially fat, liver, muscle, heart, and smooth muscle cells. Once the drug binds to PPARs, it alters how cells’ DNA affects the rest of the cells’ functions. Rosiglitazone results in reduced glucose, fatty acid, and insulin blood concentrations, which helps people with Type 2 diabetes because it decrease cell resistance to insulin.
GSK’s sales of the drug reached a record $3.2 billion in 2006. Since then multiple controversies have eroded consumer confidence in the drug, reducing sales. In 2007, the FDA placed a “black box warning,” the agency’s most serious alert, on Avandia. In September 2010, the FDA restricted Avandia to only those whose doctors could expressly show that no other drug or therapy alternative existed, but since then the FDA has eased those restrictions. At the same time, the European Medicines Agency halted sales of all rosiglitazones, and it required Avandia’s removal from the market.
Soon after, 38 state governments sued GSK for falsely claiming that Avandia provided cholesterol and cardiovascular benefits and that the drug in fact worsened them. In November 2012, without admitting it misrepresented Avandia, GSK agreed to change its marketing practices for its anti-diabetics and pay the state governments $90 million in a “consent judgment.” Oregon received $3.9 million, and $2 million went to Wisconsin.