The Food and Drug Administration has said that the manufacturer of Trasylol (aprotinin) needs to use a stronger warning associated with the drug to address the overwhelming number of risks associated with kidney damage. Bayer is being asked by the FDA to promote the use of Trasylol, a drug which is used to help reduce blood loss during coronary artery bypass surgeries, only in patients who are at elevated risks for blood loss during such procedures due to its serious health risks.
According to pharmatimes.com :
FDA began reassessing the safety of the drug earlier this year, when two separate studies suggested links to heart attack, stroke and kidney problems. In September, Bayer submitted new data to the FDA about risks of Trasylol but crucially this came days after advisory panel meeting was held to review the drug’s labelling and found it to be safe and effective when used to prevent blood loss in patients undergoing coronary artery bypass grafting.
Bayer admitted that it should have disclosed the results earlier and suspended two senior staff members as a result of the incident. A US lawyer has been called in to examine the case.
If you or a loved one has had a coronary artery bypass surgery in the past five years chances are you were given Trasylol whether you know it or not. As a result many who had this procedure and subsequently had complications as a result including but limited to kidney failure with or without the need for dialysis, heart attack and/or stroke are just now discovering that Trasylol might be to blame for these otherwise unexplained events.
For more information on the dangers associated with Trasylol read some of my other posts on this dangerous drug or send me a question via the Ask An Attorney feature. As always your consultation and information will be free of charge and kept completely confidential.
A partner with Childers, Schlueter & Smith, LLC,, Brandon Smith has devoted his practice to pharmaceutical litigation, mass torts, products liability and serious personal injury. A frequent guest speaker at legal seminars all over the country—Brandon is focused on helping injured victims nationwide, however possible. Named a SuperLawyer again in 2019, he has also been called out as one of 10 Best Attorneys For Georgia by the American Institute Of Personal Injury Attorneys and a Top 100 Lawyer in Georgia by the National Trial Lawyers in 2019.