Avandia heart failure black box warning

Harvey Kirk

By Harvey Kirk
Posted June 11, 2007


During congressional hearings on Wednesday, FDA officials indicated that they intend to ask drug makers to add a new ‘black box’ warning to Avandia and Actos.  The warning will highlight the increased risk of heart failure associated with the two drugs which are used to treat Type 2 diabetes.  The congressional hearings were held to review recent reports of Avandia heart problems, which could increase the risk of heart attacks and death.

>>INFORMATION: Avandia side effects

A ‘black box’ warning is the strongest warning the FDA can ask a drug manufacturer to place on a prescription medication.  The risk information is placed prominently on the label inside of a black box.

Heart failure is a chronic condition which occurs when the heart has difficulty pumping blood.  It is manageable if early signs are identified and it is treated with medication.  An increased risk of heart failure could lead to a heart attack. 

The FDA announcement comes amid recent concerns about Avandia’s safety.  Controversy has surrounded the drug since a report published in the New England Journal of Medicine indicated that users could have a 43% increase in the risk of having a heart attack and a 64% increase in the risk of heart related death. 

A heart attack is a much more serious risk than heart failure.   It occurs when the blood flow from the heart is stopped and could result in immediate death.  The FDA indicated that they are still reviewing the Avandia heart risks and plan to have an advisory panel meeting in July 2007 to consider what further steps should be taken.


The lawyers at Saiontz & Kirk, P.A. are reviewing Avandia lawsuits nationwide for users of who suffered a heart attack, heart failure or death.  To determine if you qualify for a potential claim, request a free consultation and claim evaluation.


1 Comment • Add Your Comments

  • Kristi E west says:

    I beleive the drug company had knowledge well in advance of notifying the public. My doctor was slow to recognize my symptoms, thus delaying any necessary workup. He was delayed in informing me that the drug I was taking was a primary reason for my dyspnea and edema and noctunal orthopnea. My pharmacist was delayed in informing me also, as I had asked questions regarding my medicines as a source for my symptoms.

    Posted on August 22, 2007 at 9:59 am

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