A February 22, 2006 internal FDA memorandum, obtained by staffers of the Senate Finance Committee, proves that safety officials within the agency recommended that GlaxoSmithKline add a black box warning about congestive heart failure to the label of the diabetes drug Avandia well over a year ago.
The memo also shows that FDA reviewer Dr David Ross recommended a highlighted boxed warning for CHF, a life-threatening condition that occurs when fluid builds up in the lungs causing a severe shortness of breath that requires immediate medical attention.
The memo also recommended that macular edema, a condition that causes swelling of the retina and can lead to blindness, be listed as a serious adverse event on the label.
Full story by Evelyn Pringle HERE
"It's not about what they tell you, it's about what they don't."
~ Bob Fiddaman, Author, Blogger, Researcher, Recipient of two Human Rights awards
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Monday, July 09, 2007
FDA Gave Glaxo Extra Year to Profit Off Avandia
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