Trasylol increases the risk of death
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The use of Trasylol may increase your risk of death, kidney failure, congestive heart failure and/or stroke.
PRESS RELEASE: October 2, 2006
Bayer Pharmaceuticals the maker of the prescription drug Trasylol, has been admonished by the U.S. Food and Drug Administration (FDA) for not sharing data on the risks associated with Trasylol (aprotinin injection).
Trasylol is a drug used during heart surgery to reduce bleeding, has been on the FDA's watch list since January 2006 when a study in the New England Journal of Medicine revealed that patients treated with Trasylol have twice the rate of kidney failure and the patients have an increased risk for heart attacks, heart failure, strokes and encephalopathy.
On September 21, 2006 at a public meeting to discuss and revisit the safety and effectiveness of Trasylol, the drug's maker failed to disclose the most updated data from its own research to the FDA. The research now confirms that the drug may increase the risk of serious side effects.
The Bayer Study, examined 67,000 hospital records of patients undergoing coronary artery bypass graft surgery. About half those patients received Trasylol while the other half was treated with alternate drugs.
The study suggests that the patients whom received Trasylol were at increased risk for death, kidney failure, congestive heart failure and/or stroke.
The FDA will further evaluate this new data, the FDA now advises the following:
Physicians should consider limiting the use of Trasylol during surgery and if used, to patient must be monitored for toxicity to their kidneys, heart or brain. The New England Journal of Medicine article maintained that stopping the use of aprotinin could prevent over 10,000 cases of kidney failure per year and save over $1 billion a year in dialysis costs.
Aprotinin is marketed by Bayer worldwide under the trade name Trasylol. The drug has been on the market for thirteen years as a drug to prevent not only excessive bleeding during surgery, but also inflammation.
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