Avandia heart attack warning added in black box

Harvey Kirk

By Harvey Kirk
Posted November 16, 2007


The FDA and GlaxoSmithKline officially announced earlier this week that an Avandia black box warning will be added to the diabetes drug regarding heart attacks.  However, many do not believe that the warning does enough to inform users about the risk of serious injury or death which could be caused by the medication

>>INFORMATION: Avandia Heart Side Effects

Many experts have called for an Avandia recall following a May 2007 report published in the New England Journal of Medicine which indicated that users of the diabetes drug could face a 43% increase in the risk of a heart attack.  Avandia already contains a black box warning which indicates that it is associated with an increased risk of heart failure, but a heart attack is a much more serious health concern where the blood supply to the heart could be stopped suddenly, with fatal consequences.

The confusing warning which GlaxoSmithKline agreed to add to the label does not describe the risks in layman’s terms, referring to an association with “myocardial ischemic events such as angina or myocardial infarction”, instead of using the commonly understood terms such as chest pain and heart attacks.  The warning also ends by indicating that the data regarding the risk is “inconclusive”, which could lead many users to feel reassured instead of helping them understand the danger associated with the drug.

The new addition to the Avandia black box warning will state:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.  Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk.  In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

Avandia was approved by the FDA in 1999 for use by type 2 diabetics to control blood sugar levels.  It remains approved in the United States for use as a stand alone treatment or in combination with metformin and sulfonylureas. 

Although there were many voices inside the FDA who felt that an Avandia recall should be issued, the FDA voted to allow the drug to stay on the market and has even allowed the drug to remain approved for use as a stand alone treatment.  Last week, drug regulators in Canada announced that they were requiring a new Avandia label which indicates that the drug should not be used alone, should only be used in combination with sulfonylureas when metformin is contraindicated and should only be used in combination with metformin when the older diabetes drug by itself does not adequately control blood sugar levels. 

David Graham, an FDA staff scientist, has spoken out against the new Avandia black box warning and indicated that he recommended an Avandia recall.  According to an article in USAToday, Graham indicated that the black box warning does not go far enough to warn users and does not indicate that other alternatives are available that are just as good as Avandia without the risk of heart attacks.

Under pressure from the FDA, Glaxo did agree to conduct a detailed study of their drug to reach a conclusion about the extent of the heart attack risk.  The study is not expected to end until March 2014, but interim results will be provided to the FDA and they may provide a clearer answer before the study concludes.


The Avandia attorneys at Saiontz & Kirk, P.A. represent individuals who suffered a heart attack, stroke or death after taking the type 2 diabetes medication.  Thousands of Avandia users are pursuing an Avandia lawsuit to seek compensation for their injuries which could have been prevented if the manufacturer had provided adequate warnings about the risk of heart problems.  If you, a friend or family member believe that you may have a claim, request a free consultation.

No Comments • Add Your Comments

Add Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide contact information below and additional private comments if you want an attorney to contact you to review a potential case.

    The information below will not be published to this page.

  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.