1997—The FDA approves Rezulin, first of the glitazone drugs that treat type 2 diabetes by helping the body use insulin more efficiently.
May 1999—The European Medicines Agency declines to approve GlaxoSmithKline’s Avandia, citing its risks of causing heart problems. Nevertheless, the FDA gives approval to Avandia, and it goes on the market in the United States.
July 1999—FDA approves Actos, the third glitazone drug.
March 2000—FDA recalls Rezulin, due to liver toxicity.
2002—An FDA internal memo shows that staff scientists have urged that the label for Avandia include a reference to its risk of side effects such as fluid retention and heart problems.
April 2002—Avandia and Actos labels get warnings about increased risk of heart failure.
2003—As part of its settlement of a Paxil lawsuit, GSK posts data from 65 studies on its website.
2004—Public Citizen’s Worst Pills, Best Pills lists Avandia as among the worst.
December 2005—GSK and the FDA notify doctors about macular edema as an Avandia side effect.
2006—Avandia generates $3.2 billion in sales; GSK strengthens its warning label.
May 2007—Dr. Steven Nissen does a meta-analysis of GSK’s data on Avandia and concludes that it increases the risk of death from heart problems by 64% and heart attacks by 43%. His results are published in the New England Journal of Medicine.
June 6, 2007—Avandia’s label gets the “black-box” warning.
June 29, 2007—The ADOPT study shows that women who take Avandia are more likely to suffer bone fractures.