Trasylol Timeline

Trasylol Litigation Timeline

The timeline below includes major Trasylol events, from FDA approval to the announcement of a new study that provides new evidence of the increased risks of congestive heart failure, stroke, kidney damage, and death with the use of Trasylol.

December 30, 1993 – Aprotinin (Trasylol) Receives FDA Approval

The Food and Drug Administration announces the approval of Trasylol, a drug used to control excess bleeding in bypass heart surgery patients.

The FDA stated that the use of Trasylol should be reserved for heart surgery patients with a high risk of excessive bleeding. During clinical trials kidney toxicity was reported as a problem in some patients.

January 20, 2006 – Trasylol Associated With Renal Toxicity

Karkouti, et al. publishes an article in the journal Transfusion suggesting a link between aprotinin and kidney problems among cardiopulmonary bypass patients.

January 26, 2006 – Risks Associated with Aprotinin in Cardiac Surgery

The New England Journal of Medicine publishes a Trasylol study article by Mangano et al. reporting an association of Trasylol (aprotinin injection) with serious kidney problems and heart attacks. The study found that patients who were given aprotinin were more than twice as likely to have kidney failure requiring dialysis, a 55% increase of heart failure and a 181% increase in stroke. The authors advised against further use of the drug, since safer, cheaper alternatives are available.

February 8, 2006 – FDA Public Health Advisory

Following two studies associating the use of Trasylol with increased risk of kidney failure, heart and central nervous problems after heart surgery, the FDA issued a public health advisory. The FDA recommended limiting Trasylol use to those situations where the clinical benefit of reduced blood loss outweighs the potential risks.

September 21, 2006 –Cardiovascular and Renal Drugs Advisory Committee

The FDA holds a public meeting to discuss the safety and overall risk-benefit profile for Trasylol. The committee supports acceptable safety and efficacy for Trasylol among coronary artery bypass graft (CABG) surgery patients.

September 27, 2006 – Additional Study Revealed by Bayer

Bayer Pharmaceuticals reveals to the FDA that it had conducted an additional Trasylol safety study. The study shows use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. The failure of Bayer to disclose the data from the additional study seriously undermined the advisory committee process and delayed the safety review.

September 29, 2006 – FDA Public Health Advisory

Federal Drug Administration announces that Bayer failed to disclose a Trasylol study prior to the September 21, 2006 public meeting held to discuss the safety of Trasylol (aprotinin). 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.

October 13, 2006 – Bayer Suspends Employees Over Trasylol Study

Following the failure to reveal a Trasylol safety study, Bayer has suspended two employees in what seems like an attempt to justify why the study was not disclosed. The safety trial results focused on the potential Trasylol risks and side effects for patients using the drug during bypass heart surgery. The suspended Bayer employees are members of the Germany Drug Safety Group.

The Federal Drug Administration began reviewing Trasylol after two published studies associated the drug with serious side effects including kidney damage, heart attacks, and stroke.

The FDA panel had concluded that Trasylol was safe and effective but issued a warning on the product after reviewing the newly revealed data. Bayer stated that it had mistakenly failed to reveal the data because of its preliminary nature and did not attempt to knowingly withhold Trasylol study data from the panel.

December 15 2006 – FDA Revises Trasylol Labeling and Strengthens Safety Warnings

Following a review of safety information conduced by the Food and Drug Administration the Trasylol labeling was changed. The review, which started in January 2006, was prompted by Trasylol studies that showed an increased risk of kidney failure, heart attack and stroke in patients who were given Trasylol during heart surgery. The new labeling limits the drugs usage to specific situations where the patient has an increased risk for blood loss during surgery.

November 5 2007 – Bayer Withdraws Trasylol From the Marketplace

Bayer stopped selling the heart surgery drug Trasylol after studies linked the drug to a 50 percent higher risk of death than other drugs in the clinical trial. The FDA requested that Bayer withdraw Trasylol from the marketplace until further studies could be reviewed.

A Trasylol class action lawsuit attorney at Fields Law Firm is available to answer any questions you may have regarding how to find out if the drug was used during open heart surgery. We will also request copies of your medical records or family member’s records at no cost to you in order to help find out if the drug was used. We are currently filing Trasylol lawsuits for individuals and families affected in all 50 states.