Avandia heart failure black box warning

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.

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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.

AVANDIA LAWYERS

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.

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