FDA Gave Glaxo Extra Year to Profit from Avandia
A memorandum acquired by the Senate Finance Committee shows that Food and Drug Administration knew that there were dangerous side effects associated with GlaxoSmithKline drug Avandia. The memo shows that Dr. David Ross, a FDA reviewer, recommended that there be a highlighted boxed warning on Avandia packaging about an increased risk of CHF. CHF is a life-threatening condition that occurs when fluid builds in the lungs and causes a shortness of breath.
The memo also recommended that a warning about an increased risk for macular edema be added to Avandia's packaging. Even though the recommendations were approved by Dr. Rosemary Johann-Liang, they never were added to Avandia's label. Congestive heart failure "is a very, very clear adverse reaction syndrome" with Avandia, said Johann-Lang. Johann-Lang has since left the FDA.
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