The timeline outlined below provides a summary of the sequence of events leading to the discovery of information regarding heart problems associated with Avandia since it was approved by the FDA.
*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
- 1999: The FDA approves Avandia for controlling blood sugar in people with diabetes.
- Fall 2006: The Lancet publishes a study showing Avandia can prevent diabetes in people at high risk. Cardiologist Steven Nissen of the Cleveland Clinic notices that the study also showed an excess rate of heart attacks, strokes, and death from cardiovascular disease, and begins studying the drug.
- May 2007: The New England Journal of Medicine publishes an analysis by Nissen of 42 studies of Avandia. His conclusion: The drug increases the risk of heart attacks by 43 percent. The FDA releases a safety alert on Avandia.
- June 2007: NEJM publishes a study by manufacturer GlaxoSmithKline showing Avandia does not cause heart problems. The House of Representatives meets to consider whether the FDA should continue to allow Avandia to be sold.
- July 2007: An FDA advisory committee concludes that there’s definitely an increased risk of heart disease, but the drug should be left on the market because it’s so effective at controlling blood sugar.
- November 2007: At the request of the FDA, the manufacturer puts a “black box” warning on Avandia.
- February 2010: Congress weighs in again: The Senate Finance Committee accuses the manufacturer of holding back data that shows problems with Avandia.
- May 2010: Studies in the Journal of the American Medical Assocation and the Archives of Internal Medicine show that Avandia increases the risk of cardiovascular problems. The JAMA study comes from the FDA, and includes data from 227,000 patients. The lead researcher concludes that for every 60 people on the drug for a year, there’s an extra heart attack, stroke, heart failure or death.
- July 13 and 14, 2010: The FDA convenes another advisory committee meeting to vote on whether to take Avandia off the market.
- 2015: The manufacturer is expected to release results of a large trial designed to answer the question of whether Avandia causes heart problems. Some people want this trial called off, saying the drug is dangerous.