Avandia Focus Of Petition By Public Citizen
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Type-2 diabetes drug Avandia once showed great promise in reducing blood glucose levels in patients. GlaxoSmithKline thought they had a winner on their hands. But then the reports of heart and liver damage.
Now the consumer group, Public Citizen wants the Food and Drug Administration to take Avandia off of the market and has filed a petition to that end. GSK can’t blame just the consumer group. Just last week, the American Diabetes Association and a European health group recommended doctors stay away from Avandia.
"The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities," Public Citizen said in its petition. "Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure."
The FDA, always willing to give drug companies a break, says it will review the petition and keep an eye on Avandia's safety record.
None of this is new. One year ago, The New England Journal of Medicine linked Avandia use to heart attacks risks. That resulted in a stronger warning and a drop off in patient prescriptions. Still about 10,000 prescriptions are being filled daily.
Public Citizen names 14 cases of liver failure linked to Avandia use. 12 people died. GSK says it does not agree with that assessment.
Here is the petition by Public Citizen.
Avandia is also known as rosiglitazone.