FDA Warning on Trasylol (aprotinin injection)

FDA warnings on Trasylol reflect the potential dangers of this drug.

On September 27, 2006, Bayer Pharmaceuticals alerted the FDA to the findings of a study conducted on their popular drug Trasylol. The preliminary results of this study confirmed the suspicions the FDA had had since January 2006 that Trasylol potentially increased the likelihood of death, congestive heart failure, strokes, and serious kidney damage.

As recently as September 21, 2006, the FDA held a meeting of the Cardiovascular and Renal Drugs Advisory Committee in order to determine if they should revise their risk-benefit profile of Trasylol. The committee was not at the time aware of the findings of Bayer's study, but initiated their investigation based on two previous studies that linked Trasylol to heart and kidney damage.

Trasylol is used to reduce bleeding and the need for blood transfusions during major operations such as coronary artery bypass graft surgery and other procedures where loss of blood is a critical factor. Extracted from the lung tissue of cattle, Trasylol was intended to save lives, rather than endanger them.

Recent study on Trasylol.

This recent study examined hospital data from the records of 67,000 patients that underwent a coronary artery bypass graft surgery. 30,000 patients were treated with Trasylol and 37,000 were treated with other forms of drugs that aimed to accomplish the same effect. The study used complicated epidemiological and statistical methods to suggest that Trasylol patients were more likely to suffer kidney failure, congestive heart failure, stroke, and death than the patients receiving other treatment.

If you are one of the thousands of people that were given Trasylol, you may already be suffering the side effects of this dangerous drug. Let our experienced and dedicated Trasylol lawyers help you fight for your rights and get you the compensation you may deserve. Contact us today.

The Food and Drug Administration has released a public health advisory on Trasylol in response to an article published by the New England Journal of Medicine in January of 2006. These FDA warnings on Trasylol were caused by findings that reported an association of the drug with serious renal toxicity and ischemic events in patients undergoing CABG surgery.

While they evaluate the drug and the findings presented by the New England Journal of Medicine, the FDA has offered specific recommendations to healthcare providers and patients. FDA warnings on Trasylol reflect the potential dangers of the drug to patients of coronary artery bypass grafting surgery.

The first FDA recommendation is directed towards physicians who use Trasylol. These doctors should continuously monitor patients for kidney, heart, or central nervous system toxicity. If toxicity has occurred, adverse effects must be reported to Bayer.

The second FDA recommendation is to limit the use of Trasylol. The Food and Drug Administration considers the drug so dangerous that is should only be used in situations where the clinical benefit of reduced blood loss is essential. If the potential benefits of Trasylol are outweighed by its risks, the use of the drug should be avoided. There are safer and less expensive alternatives to Trasylol usage.

If you have experienced health problems after being prescribed Trasylol, it is essential that you are aware of your legal rights. Nobody deserves to be subjected to the risks of a drug that is more dangerous and expensive than its alternatives. If your health has been jeopardized by a Trasylol injection, contact an experienced Trasylol lawyer today.