Trasylol, a controversial heart surgery drug, will be removed from shelves after a Canadian study found an increase of risk of death among surgery patients who were given the drug. The company that distributes the drug, Bayer AG, was put under pressure from medical regulation agencies around the globe to remove the drug. However, Bayer AG has made statements claiming that the drug is still beneficial. Despite this, the study conducted by the Ottawa Health Institute had to be closed after it was found that heart and valve surgery patients who had been given Trasylol had an increased risk of death in comparison to those who had been administered the two older antifibrinolytic drugs that were also used in the study.
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. The FDA was alerted to the study by one of the researchers involved. Although the FDA issued a statement of concern they did not change their recommendation that the drug may benefit certain subpopulations of patients. On October 3, 2006, the FDA issued a Public Health Advisory Update recommendation 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 assiduously monitor the patients who have been given the drug. Due to the necessity for such drugs in hear surgery, the FDA did not recommend any withdrawal or Trasylol recall, but did issue a new Trasylol warning label to strengthen safety warnings concerning 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. You can obtain any advice needed relating to a potential Trasylol lawsuit today!
