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.

The two generic drugs have proven safe in limiting blood loss, and do not have the harmful effects of Aprotinin.

Patients scheduled for cardiac surgery are advised to consult their physicians and avoid this risk.

Aprotinin was approved by the U.S. Food and Drug Administration in 1993 and is manufactured by Bayer under the brand name Trasylol.

Over the past three years, Trasylol sales have accelerated.

Dr. Mangano estimates that as many as 10,000 patients may be unnecessarily on dialysis today due to Aprotinin use.

He believes such a serious impact on human lives underlines once again the necessity for meticulous, post approval surveillance, as well as ongoing, unbiased analysis of drug safety and all should be conducted by entirely independent entities.

He declares this is easier said than done, as economic pressures will continue to be substantial, with little corporate incentive to identify safety problems once drugs are approved and marketed.

The nonprofit Ischemia Research and Education Foundation provided a total of $35 million to fund the study, including site grants, central analysis and data disposition and manuscript grants.

The good will of the 69 participating McSPI cardiac centers in the U.S. and worldwide contributed similar, in kind support through reduced research and data collection fees.

None of the authors received direct or indirect support from any of the manufacturers of these three drugs.

This is the fourth major cost-saving therapeutic discovery by Dr. Mangano and IREF-McSPI colleagues over the past decade.

All have saved lives and money.

The full article is available in the current edition of the New England Journal of Medicine.