Avandia Timeline
1999—GlaxoSmithKline’s Avandia wins FDA approval for the treatment of type 2 diabetes.
1999—Dr. John Buse sees a trend in heart problems among Avandia patients and makes his concerns public. He is soon contacted by GSK officials, who threaten to take him to court, so he writes a "clarifying letter" to soothe stockholders and investors.
March 2000—Dr. Buse refuses to be silenced. He writes to the FDA about the high number of patients who have suffered Avandia heart problems.
2000—The watchdog group Public Citizen cites an FDA internal memo which shows concern about the risk of heart failure with Avandia.
2002—The FDA issues a warning about Avandia’s tendency to cause fluid retention and weight gain—often precursors to heart problems.
2003—As part of its settlement of a Paxil lawsuit, GSK puts the results of its clinical trials on the company website. Dr. Steven Nissen will use this data for a meta-analysis to determine the heart risks presented by Avandia.
2005—GSK provides the FDA with data that apparently links Avandia with an elevated risk of such side effects as heart problems and heart attacks. Neither the company nor the agency, however, notify the public.
2006—Some 13 million prescriptions are written for Avandia, with sales of more than $2 billion.
2006—The FDA strengthens its warning on the label of Avandia.
May 2007—The New England Journal of Medicine publishes a study concluding that people taking Avandia have a 64% greater risk of death from heart problems and are 43% more likely to have heart attacks than those taking other drugs or placebo.
June 2007—Dr. Andrew von Eschenbach of the FDA announces that Avandia will get a "black-box" warning.
June 2007—GSK faces a U.S. investor lawsuit which claims that it misled shareholders about the safety of Avandia.
June 29, 2007—Results come in from the ADOPT study, a multicenter, randomized, double-blind clinical trial involving 4,360 patients. They show that women who take Avandia are at an increased risk of suffering bone fractures.
2009—RECORD is a large, long-term clinical trial designed specifically to determine the cardiovascular risks of Avandia. RECORD, which is being conducted by GSK, is not expected to be completed before this year.
