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Another FDA Warning? 10.24.07

in this section: Avandia Problems

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New Avandia Setback? Possible Second Black Box Warning on Heart Attack

The Food and Drug Administration would like to include the strongest safety warning about heart attack risk to Avandia's label, reported the Wall Street Journal on October 24, 2007.

This new addition would be the second so-called "black-box warning" to be added to the Avandia label. The first one carries a warning about heart failure--another side effect of the dangerous Type 2 diabetes drug.

The FDA is reportedly still in discussions with GlaxoSmithKline about adding the warning.

An FDA analysis found that Avandia seems to be linked to a 38 percent higher risk of events in which blood is choked off from the heart in users.

If you or a loved one has suffered cardiac complications after ingesting Avandia, you deserve the guidance of a knowledgeable drug attorney. Get a free case review by filling out the form below.

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see also:

Avandia Problems Glaxo Failed to Alert FDA about Avandia Studies That Revealed Problems
FDA sends letter to Glaxo on failure to inform of Avandia's problems

Avandia Diabetes Pills Glaxo Failed to Disclose Studies Regarding Avandia Diabetes Pills
FDA wasn't told about safety reports on Avandia Pills--lawsuit info

News & Warnings Avandia Breaking News: Glaxo Warned in 2001 about Misleading Marketing
Bloomberg News: FDA Warned Glaxo about Avandia Marketing in 2001

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