May 1999—GlaxoSmithKline’s Avandia wins Food and Drug Admistration approval for the treatment of type 2 diabetes.

June 1999—Actos, a rival diabetes drug, receives approval from the FDA

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 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.

February 2007—GSK sends a letter to doctors alert them of a study which found that women taking Avandia were significantly more likely to suffer fractures than those who were taking older diabetes medications.

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  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.

July 2007—An FDA panel rules that Avandia causes an increased risk of heart attacks for diabetics taking the drug.

November 2007—The FDA adds a black box warning to Avandia’s labeling about the potentially increased heart attack risk for patients who are prescribed the drug.

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.

February 2010—The Senate Finance Committee issues a report which finds that GSK was aware of the potential side effects risk of Avandia years before the information became public.

July 2010—An advisory panel for the Food and Drug Administration votes to either withdraw Avandia from the market or place new restrictions on who can be prescribed the drug due to its risk for causing heart attacks. The panel stated that it will release a decision “as soon as possible” on whether to issue a recall or to issue new warnings about Avandia.

September 2010—The FDA announces that only patients who have been unsuccessful at controlling their blood sugar levels with other diabetes drugs will be allowed to take Avandia. The agency’s announcement came after reviewing several studies which examined the side effects risk of the drug.

May 2011—The FDA announces that it will pull Avandia from retail stores beginning in November 2011. Under new guidelines, Avandia will only be available for sale through special online pharmacies to patients who have not been able to control their diabetes symptoms with other drugs.