A drug approved by the FDA, and sold worldwide for the last 13 years, has now been proven to double a patient's risk of kidney failure, and increase the risk of heart attack, heart failure, and stroke.
The drug Aprotinin has been given to an estimated one million surgery patients to limit bleeding.
These results are based on an independent, observational study conducted by the Ischemia Research and Education Foundation (IREF), in association with the McSPI Research Group, both nonprofit biomedical research organizations, dedicated to saving and extending lives.
IREF and McSPI founder and principal scientist, Dennis T. Mangano, Ph.D., M.D.says the study, which comes hot on the heels of the Vioxx experience,indicates that the problem of drug safety is not only common, but is also much more elusive than previously thought.
He says the study provides compelling evidence of Aprotinin's serious risks, and strongly suggests discontinuation of use and replacement with either of the two alternative generic and far less costly medications proven safe in this study to be safer.
Mangano says their findings raise even more troubling concerns, as Aprotinin has been on the market for three times as long as Vioxx, and yet few comprehensive safety studies have been conducted since approval; the life-threatening complications found with Aprotinin occurred far more frequently than those with Vioxx, and far less expensive generic alternatives to Aprotinin which are equally effective in limiting bleeding have been available, but have been underused.
According to the study replacing Aprotinin with one of two safe generic drugs would annually prevent as many as 11,050 dialysis complications, save at least $1 billion in healthcare (dialysis) costs, and reduce drug costs by at least $250 million.
Figures show that each year approximately one million patients worldwide undergo surgical treatment following a heart attack, with the majority of these patients receiving one of three antifibrinolytic agents to limit blood loss during surgery, Aprotinin produced by Bayer Healthcare, or one of the generic drugs aminocaproic acid and tranexamic acid.
I can recall more than one cardiac surgeon that swore by Aprotonin to prevent massive bleeding for their high risk patients. Some believed that the drug needed to be used on all redo CABG's. I think they're going to have to rethink those ideas. I keep wondering how dangerous drugs like this can get past the finicky FDA.
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