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.

TRASYLOL SEARCH

BOOKMARK THIS SITE
FIELDS LAW FIRM

We are a Law Firm that is dedicated to helping people who have been affected by Trasylol side effects.


Personal Injury Law Firm

Trasylol Categories
STAY UPDATED

TRASYLOL ARCHIVES
TRASYLOL LAWYER





FREE CASE CONSULTATION

Name:
Email:
Phone:
State:
Message:
RECENT TRASYLOL ARTICLES
Trasylol Lawsuits | Trasylol Bayer News

We represent all Trasylol lawsuits clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Trasylol lawyer will contact you to answer any of [...]

Aprotinin Drug Trasylol | Class Action Lawsuit

Trasylol Aprotinin Side Effects Study
Another study reveals an increased risk of serious Trasylol side effects leading to a higher mortality rate in aprotinin bypass patients. A recent study published in The New England Journal of Medicine on February 21, 2008 shows an increased risk of death for patients receiving aprotinin (Trasylol) during coronary-artery bypass grafting [...]

Class Action Trasylol Updates | Heart Surgery Drug

Trasylol Heart Surgery Drug Information
What is aprotinin injection?
APROTININ (Trasylol) is a drug that affects the way blood clots. It was given to heart surgery patients during bypass procedures. Aprotinin was mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding before and after surgery. Trasylol and other clotting medications help to [...]

Trasylol Side Effects | Trasylol Litigation News

An increasing number of studies have suggested Trasylol is a potentially dangerous drug and an expensive one. The cost per dose of Trasylol is $1,300. The generic drug Amicar is $11 per dose and the generic Cyklokapron is $44 per dose. According to the studies, neither of the generic drugs has been associated with an [...]

Trasylol Lawsuit News | Trasylol Recall

Patients and families nationwide have looked at filing a Trasylol lawsuit based on the often fatal side effects of the drug Trasylol. Currently no Trasylol class action suits have been filed by Fields Law Firm and claims are being made individually.
The lawsuits claim that Bayer, the drug’s manufacturer, was negligent in several ways including:
• marketing [...]

Copyright 2008 Fields Law Firm. Trasylol Class Action Lawsuit. Read Our Disclaimer Trasylol lawsuit news updates. Trasylol lawyer representing patients related to Aprotinin renal failure, class action Trasylol, drug Trasylol and kidney failure. Trasylol attorney working with families of Trasylol heart surgery patients in filing Trasylol lawsuits. Information on Trasylol Bayer side effects, Trasylol litigation from Trasylol attorneys for clients in Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, D.C., Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.

Talk To A Lawyer Now And Get Your Free Case Review - (612) 370-1511 / (888) 343-5375