Trasylol used during Heart Surgery has Serious Side Effects- Lawyers may have Lawsuit

February 22nd, 2006

Researchers reported in the New England Journal of Medicine found that Bayer’s Trasylol (generic is Aprotinin) which is used during heart surgery to prevent excessive blood loss has serious side effects.  Trasylol has double the risk for kidney failure and stroke and increases the risk of heart failure or heart attack by 55 percent. 

The FDA announced on February 8th that there is a public health advisory for Trasylol due to the recent study.  The FDA recognizes that there are two recent scientific publications that found a link for kidney problems, heart attacks and strokes for patients that used Trasylol during artery bypass graft surgery.  The FDA is sending the warning out to surgeons that perform these operations.

"FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications," stated Dr. Steven Galson the Director of FDA's Center for Drug Evaluation and Research. "We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients."

In the meantime, Parker & Waichman, LLP, is consulting victims that have been treated with Trasylol.  They estimate that since alternative drugs could have been used that are cheaper and safer, the serious side effects of Trasylol were not necessary.  The legal firm stated on their website that alternatives are available that are safer and cheaper.  The cost of Trasylol is on average, $1,300 per dose, where alternative drugs are much cheaper. They are Amicar at $11 per dose and Cyklokapron at $44 per dose.  The legal firm, Parker & Waichman, LLP, said on their website that “The researchers estimated that cessation of Trasylol in favor of a generic drug would save 9,000-11,000 people from kidney dialysis each year.”

Bayer is disputing the claims of the recent reports for safety concerns.  Bayer has collected over 15 years of clinical data which contradicts this recent research.  The FDA recognizes that the recent study could be representative of patients that were more ill than others.  This could be the reason for the higher rates of kidney failure, heart attack, and stroke.  The FDA will be reviewing the recent research studies to see if there is anything that may have thrown the data off.

The FDA will be discussing this further to determine the course of Trasylol.  The FDA says that Trasylol (aprotinin injection) is the only FDA approved product that will prevent peri-operative blood loss and lessens the need for blood transfusion during coronary artery bypass graft surgery.

The FDA recommends surgeons limit the use of Trasylol unless absolutely needed.  If there are any problems with a patient’s health due to the use of Trasylol, doctors are encouraged to report this to the FDA’s Medwatch or Bayer, the manufacturer of the drug.

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