Trasylol Manufacturer Removes Trasylol from Shelves after Increased Risk of Death Found

Under pressure from medical regulation agencies around the globe, the manufacturer of Trasylol (generic Aprotinin) announced on November 5, 2007 that it would remove the controversial heart surgery drug after a study conducted in Canada appeared to show an increased risk of death among patients on whom the drug was used. The drug's maker, German pharmaceutical firm Bayer AG, has stated that it still believes the drug to be beneficial. However the study in question, conducted by the Ottawa Health Institute, had to be stopped after it appeared that among the heart and valve surgery patients in the study, though those given Trasylol had increased risk of death, compared to those patients given two older antifibrinolytic drugs 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. Thus, the FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for reducing bleeding during surgery. Therefore, at this point there will be no complete Trasylol recall. 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. 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. 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.

This trend of potentially dangerous findings concerning Trasylol illustrates sometimes that once a drug is approved by the FDA, halting its sale is exceedingly 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!