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Avandia, manufactured by GlaxoSmithKline, is the brand name for the diabetes drug rosiglitazone, which is intended to help people with type 2 diabetes control their blood sugar levels. It was approved by the FDA in May of 1999 and quickly became the world’s best-selling type-2 diabetes drug.
Heart disease and stroke are the number one causes of death and disability among patients with type-2 diabetes. However, it was determined that Avandia increased the risk of heart attacks among those suffering from type-2 diabetes. Yet even after a 2007 study linked the drug to increased levels of heart attack and stroke in type-2 diabetes patients, the drug continued to be prescribed.
According to some experts, Avandia may have caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006. The lead author of the 2007 study published in The New England Journal of Medicine, Dr. Steven E. Nilsson, estimated that Avandia users faced a 43 percent higher risk of a heart attack or other cardiovascular events. In November of 2007, the FDA required the addition of a “black box” warning to Avandia labels.
A 2008 report by the Federal Drug Administration implicated Avandia in an estimated 83,000 heart attacks. Other studies cited additional negative side effects caused by Avandia including stroke, osteoporosis, bone fracture, and liver failure.
GlaxoSmithKline’s profits from Avandia were $3.2 billion in 2006, but dropped to $1.19 billion by 2009. The company paid a $2.36 billion charge in 2010 to settle some 10,000 of 13,000 Avandia civil lawsuits it was facing in the U.S., as well as investigations over its antidepressant Paxil and manufacturing problems in its Puerto Rico plant.
In November 2011, the pharmaceutical giant agreed to pay the U.S. government $3 billion to resolve civil and criminal investigations alleging that the company had paid doctors and manipulated medical research to promote Avandia. In January 2012, GlaxoSmithKline agreed to resolve more than 20,000 cases alleging their diabetes drug Avandia causes heart attacks.
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