Trasylol Recall Time line

By April 3, 2008Drug Safety

Trasylol also known as Aproptinin was recalled in November 2007 after it was linked to kidney damage which is also referred to as renal failure. My law firm represents over fifty plaintiffs who have suffered renal failure after being given Trasylol during cardiac artery bypass surgery. Below is a time line for the events leading to its recall
Dec. 30, 1993 – Aprotinin (Trasylol) Receives FDA Approval
The Food and Drug Administration announces the approval of Trasylol (Aprotinin). The drug is used to control excess bleeding in bypass heart surgery patients but the FDA also states that Trasylol should be reserved for heart surgery patients with a high risk of excessive bleeding. The FDA notes that kidney toxicity was reported as a problem in some patients during clinical trials.
Jan. 20, 2006 – Trasylol (Aprotinin) Associated With Renal Toxicity
A study is published in the medical journal Transfusion by Keyvan Karkouti and several other researchers suggesting that there is a link between Aprotinin and kidney problems among cardiopulmonary bypass patients.
Jan. 26, 2006 – Risks Associated with Aprotinin (Trasylol) in Cardiac Surgery
The New England Journal of Medicine publishes an article by Dennis Mangano and several other researchers with the Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation. The researchers find a link between Trasylol and serious kidney problems and heart attacks. The study finds that patients who were given Aprotinin were more than twice as likely to have kidney failure requiring dialysis, a 55 percent increase of heart failure and a 181 percent increase in stroke. The authors advise against further use of the drug, since safer, cheaper alternatives are available.
Feb. 8, 2006 – FDA Public Health Advisory
Following two studies associating the use of Trasylol (Aprotinin) with increased risk of kidney failure, heart and central nervous problems after heart surgery, the FDA issues a public health advisory. The FDA recommends limiting Trasylol use to those situations where the clinical benefit of reduced blood loss outweighs the potential risks.
Sept. 21, 2006 –Cardiovascular and Renal Drugs Advisory Committee
The FDA holds a public meeting to discuss the safety of Trasylol. The committee effectively endorses the safety of Trasylol.
Sept. 27, 2006 – Additional Study Revealed by Bayer
Bayer reveals to the FDA that it had conducted an additional Trasylol safety study. The study of a 67,000-patient database shows use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. The study was not disclosed to the FDA committee that met only the week before to discuss the drug’s safety. The failure of Bayer to disclose the data ignites a furor within the FDA.
Sept. 29, 2006 – FDA Public Health Advisory
The FDA announces that Bayer failed to disclose a Trasylol study prior to the Sept. 21, 2006 public meeting held to discuss the drug’s safety. The FDA warns doctors who administer Trasylol to carefully monitor their patients for any adverse events, in particular, problems with the kidneys, brain or heart. Physicians treating Trasylol patients are also encouraged to report any Trasylol problems to the FDA or Bayer Pharmaceuticals.
Oct. 13, 2006 – Bayer Suspends Employees over Trasylol Study
Following the failure to disclose the Trasylol safety study, Bayer suspends two employees who are members of the Germany Drug Safety Group.
The Federal Drug Administration begins a review of Trasylol after two published studies associated the drug with serious side effects including kidney damage, heart attacks, and stroke.
Dec. 15 2006 – FDA Revises Trasylol Labeling and Strengthens Safety Warnings
Following a review of safety information, the FDA strengthens Trasylol’s warning label. The label advises physicians that the drug increases the possible risk for kidney damage.
Nov. 5, 2007 – Bayer Agrees to Suspend Trasylol Marketing
Bayer agrees to suspend the marketing of Trasylol until a review of the preliminary results of a Canadian study is completed.
Feb. 21, 2008 – Two Studies in NEJM Confirm Trasylol Increases Risk of Death
The New England Journal of Medicine releases the Bayer-funded study and a second study conducted by Duke University Medical Center researchers. Both confirmed that patients given Trasylol during heart surgery were more likely to die than patients given a comparable drug.
The lawyers of Carey, Danis & Lowe are experienced in helping people injured by Trasylol. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.
We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you at the hospital or your home.