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Titled: Manufacturer of Trasylol, Bayer AG, Finds Increased Risk of Death, Removes Trasylol from Shelves
Manufacturer of Trasylol, Bayer AG, Finds Increased Risk of Death, Removes Trasylol from Shelves
Article Summary: Trasylol (or generically, Aprotonin) is a contradversial heart surgery drug. After studies in Canada linked Trasylol to a higher chance of death, however, the drug has been removed from marketing. Trasylol is used because it slows down the breakdown of blood clots during surgery. Bayer AG, the drug's German pharmaceutical firm, was faulted for not mentioning studies that said that the drug was mor
On November 5, 2007, the manufacturer of a heart surgery drug, Bayer AG, pulled a heart surgery drug called Trasylol off of the shelves. The choice was made after medical regulation agencies pressured Bayer AG to remove the drug as a result of a Canadian study that found that Trasylol was connected with an increased risk of death for heart surgery patients who were given the drug. Despite the findings in the study, Bayer AG stated that it continues to believe that the drug is advantageous. Trasylol was tested by the Ottawa Health Institute along with two older antifibrinolytic drugs, but the study had to be stopped when it was found that patients who were given Trasylol exhibited a higher risk of death than patients given the two older drugs.
Antifibrinolytic drugs such as Trasylol are used during heart surgery because they slow the breakdown of blood clots during, and thus can prevent excessive bleeding. According to the Food and Drug Administration (FDA) there are not many alternatives when it comes to patients at risk for excessive bleeding during heart surgery. In order to not cause shortages of the other choices of drugs that are used to reduce the bleeding during surgery, the FDA and Bayer are working together to phase Trasylol out of the marketplace. As a result of this, there will be no entire repeal of Trasylol at this point. However, these recent negative findings concerning Trasylol are only the next in a long line of safety concerns and warnings that have been documented by the FDA.
In September 2006, Bayer A.G. was faulted by the FDA for not revealing during testimony the existence of a commissioned retrospective study that concluded Trasylol carried potentially greater risks than other similar antifibrinolytic drugs. One of the researchers participating in the study alerted the FDA. Although the FDA issued a statement of concern they did not change their recommendation that the drug may benefit certain subpopulations of patients. In a Public Health Advisory Update dated October 3, 2006, the FDA recommended that "physicians consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is necessary to medical management and outweighs the potential risks" and carefully monitor patients. Drugs for heart surgery are limited and so, because of the necessity for these drugs, the FDA was hesitant about recommending a withdrawal of Trasylol, but it did issue a warning label for the drug in order to strengthen warnings concerning safety and using Trasylol.
The studies concerning Trasylol that have found that it is a conceivably dangerouns drug have inllustrated that once a drug is accepted by the FDA, stopping its sale is extremely difficult. Experts on FDA advisory panels are often hesitant to take widely used medicines out of doctors' hands, even when their safety is uncertain. For this reason it is important for anyone who may have had Trasylol used during a surgical procedure to consult with their doctor about the potential risks involved. The need for serious consultation concerning the safety of Trasylol is perhaps even more important for those who may potentially require Trasylol in a future surgical procedure.
For anyone who believes that, in addition to a medical consultation, they might require any kind of legal advice, contacting an experienced Trasylol law firm may be the best course of action. A Trasylol lawyer experienced in the intricacies of the complex situation involved in this case would be able to offer guidance and information to anyone who may have been affected, or who may have had a loved one affected. Getting in touch with an expert Trasylol attorney can be as easy as filling out the Trasylol lawyer case evaluation form at the top or bottom of this page. Get advice you need on any potential Trasylol lawsuit today!
Article Source: http://www.upublish.info
About the Author:
Peter Kent
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