Posted: 11-18-10 Categories:
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Avandia Timeline: Diabetes Drug Side Effects, FDA Warnings


May 1999: Avandia is approved by the FDA for controlling blood sugar in people with Type 2 diabetes.

April 2002: Avandia warning label is strengthened to more clearly describe cardiovascular risks, including fluid retention that may lead to congestive heart failure (CHF).

August 2006: Avandia manufacturer GSK provides the FDA a meta-analysis of 42 controlled Avandia clinical drug trials suggesting short-term Avandia use may be linked to a 30%-40% greater risk of heart attack and other adverse cardiovascular events compared with other diabetes treatments or no anti-diabetic therapy at all.

May 2007: Cleveland Clinic cardiologist Dr. Steven Nissen publishes his meta-analyis of the 42 Avandia trials in the New England Journal of Medicine.  Dr. Nissen concludes that Avandia use is associated with a 43% increase in heart attack risk and a 64% increase in the risk of death from cardiovascular causes.  In response, the FDA issues a safety alert on Avandia.

June 2007: A GlaxoSmithKline study purporting to show that Avandia does not cause heart problems is published in the New England Journal of Medicine.  A congressional hearing is held to consider FDA approval and post-market investigation of Avandia heart attack risks.  Congress begins investigating whether the FDA should order an Avandia recall.

July 2007: A joint FDA drug safety advisory committee votes against an Avandia recall despite the increased risk of heart attack and cardiovascular problems associated with  use of the diabetes drug.  Avandia’s benefits still were believed to outweigh its risks.  Members of the joint committee voted 22-1 to recommend that information warning of potential for increased risk of heart attacks be added to the drug’s labeling.

November 2007: The FDA adds a “black box” warning for heart attack risks to Avandia label and package insert.  The FDA action follows the recommendations made at the July 2007 FDA joint drug safety advisory committee meeting.

February 2010: A Senate Finance Committee report linking Avandia to increased risks of heart attacks and other cardiovascular events is released.  The report is critical of GlaxoSmithKline’s conduct in the sale and marketing of the diabetes drug.  Avandia manufacturer GlaxoSmithKline is found to have known of Avandia risks for years, but worked to conceal risks of the drug from diabetes patients and the FDA.

May 2010: Two major studies, published in JAMA and Archives of Internal Medicine, show an association between the use of Avandia and increased risks of heart attack and other cardiovascular problems.

July 13 and 14, 2010: A second FDA joint drug safety advisory committee meets to consider the risks and benefits of Avandia.  The committee votes 20-12 against recommending an Avandia recall (16 also had voted at the 2007 meeting).  Instead, it advises the FDA to add additional safety warnings to the Avandia label and impose new restrictions on its use.

September 23, 2010: The FDA announces tight new restrictions on use of the diabetes drug Avandia by patients with Type 2 diabetes who cannot control their diabetes on other medications.  An agency spoken stated, “FDA is taking this action in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.”

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