Trasylol Indication
Trasylol® is indicated for prophylactic use to reduce perioperative blood loss and the need for blood
transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft
surgery who are at an increased risk for blood loss and blood transfusion.
Trasylol Side Effects, Risk and Warning
Trasylol® administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have
occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal
reactions have also occurred in situations where the initial (test) dose was tolerated. Please, review the
product insert for other Trasylol side effects.
Source of Information for Trasylol Indication and Trasylol Side Effects: Product Insert September 17, 2011
________________________________________________________________________________
Trasylol Lawsuits
Bayer Pharmaceuticals Corp. (Bayer) may face many Trasylol lawsuits. The U.S. Food and Drug
Administration (FDA) announced on November 5, 2007 that, at the agency's request, Bayer agreed to a
marketing suspension of Trasylol, pending detailed review of preliminary results from a Canadian study that
suggested an increased risk for death.
FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes
suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with
Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to
undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.
There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery.
Thus, 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 this purpose.
Until FDA can review the data from the terminated study it is not possible to determine and identify a
population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks.
Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is
committed to exploring ways for those doctors to have continued, limited access to Trasylol.
Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on
Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic
drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent
excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients
receiving the drug experienced serious bleeding events.
On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to
the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety
warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion
during coronary bypass graft surgery.
Schmidt & Clark LLP reports that there are about 22,000 deaths associated with the use of Trasylol. If you or
a loved one have undergone heart surgery and subsequently developed kidney or renal failure and are now
undergoing dialysis treatments or have passed away, you should contact lawyers to assess if you are
entitled to compensation by filing a Trasylol lawsuit.
Reference
[1] FDA Safety Alert November 5, 2007.
[2] http://www.schmidtandclark.com/trasylol
________________________________________________________________________________
Trasylol® is indicated for prophylactic use to reduce perioperative blood loss and the need for blood
transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft
surgery who are at an increased risk for blood loss and blood transfusion.
Trasylol Side Effects, Risk and Warning
Trasylol® administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have
occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal
reactions have also occurred in situations where the initial (test) dose was tolerated. Please, review the
product insert for other Trasylol side effects.
Source of Information for Trasylol Indication and Trasylol Side Effects: Product Insert September 17, 2011
________________________________________________________________________________
Trasylol Lawsuits
Bayer Pharmaceuticals Corp. (Bayer) may face many Trasylol lawsuits. The U.S. Food and Drug
Administration (FDA) announced on November 5, 2007 that, at the agency's request, Bayer agreed to a
marketing suspension of Trasylol, pending detailed review of preliminary results from a Canadian study that
suggested an increased risk for death.
FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes
suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with
Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to
undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.
There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery.
Thus, 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 this purpose.
Until FDA can review the data from the terminated study it is not possible to determine and identify a
population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks.
Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is
committed to exploring ways for those doctors to have continued, limited access to Trasylol.
Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on
Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic
drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent
excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients
receiving the drug experienced serious bleeding events.
On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to
the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety
warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion
during coronary bypass graft surgery.
Schmidt & Clark LLP reports that there are about 22,000 deaths associated with the use of Trasylol. If you or
a loved one have undergone heart surgery and subsequently developed kidney or renal failure and are now
undergoing dialysis treatments or have passed away, you should contact lawyers to assess if you are
entitled to compensation by filing a Trasylol lawsuit.
Reference
[1] FDA Safety Alert November 5, 2007.
[2] http://www.schmidtandclark.com/trasylol
________________________________________________________________________________
| Trasylol Lawsuit, Trasylol Side Effects |
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This website discusses the benefits and side effects of various supplements, herbs and drug products.
Different people may experience different side effects and benefits of a product. You are encouraged to
report adverse side effects to FDA, its website is www.fda.gov., or report the adverse side effects to the
manufacturer, you should be able to find the contact information on the label.
There are always new information. Please, send me an email (zhion@zhion.com) to correct my mistake(s).
Reasonable care has been taken in preparing this document and the information provided herein is believed
to be accurate. The information is not intended to be a substitute for professional advice. It is important to
seek the advice of a physician about any medical condition or symptom or the benefits and side effects of a
supplement or a drug product, it is also important to seek the lawyer's advice on any legal claim.
ALL RIGHTS RESERVED 2011
Different people may experience different side effects and benefits of a product. You are encouraged to
report adverse side effects to FDA, its website is www.fda.gov., or report the adverse side effects to the
manufacturer, you should be able to find the contact information on the label.
There are always new information. Please, send me an email (zhion@zhion.com) to correct my mistake(s).
Reasonable care has been taken in preparing this document and the information provided herein is believed
to be accurate. The information is not intended to be a substitute for professional advice. It is important to
seek the advice of a physician about any medical condition or symptom or the benefits and side effects of a
supplement or a drug product, it is also important to seek the lawyer's advice on any legal claim.
ALL RIGHTS RESERVED 2011
Drug Lawsuits- Do you have a case?
Drug lawsuits are personal injury cases in which drug users injured after taking the drug seek compensation
from the drug manufacturer. Drug lawsuits can win settlements for affected users by proving that:
[A] An user's injuries were actually caused by taking the drug.
[B] The manufacturer knew about the severe drug side effects but they failed to disclose them to the FDA and
the general public.
Users who develop one or more of the unexpected side effect(s) will likely have a viable legal claim and will be
entitled to compensation for their injuries. Families of users who have died due to the drug side effects may
also be entitled to monetary settlements for their loss. Injured patients should meet with a personal injury
lawyer for an initial consultation. During this meeting, injured patients should be able to find out if they have a
provable case against the manufacturer. Most drug lawyers work on contingency – meaning that plaintiffs
won't have to pay for legal services until (or, in some cases, unless) they win a settlement. Injured users
should consult with a lawyer to see if they can start a drug lawsuit and if it is better to file an individual lawsuit
or join a class action case.
______________________________________________________________________________
Lawsuits are being evaluated nationwide for injuries caused as a result of the following drugs:
Drug lawsuits are personal injury cases in which drug users injured after taking the drug seek compensation
from the drug manufacturer. Drug lawsuits can win settlements for affected users by proving that:
[A] An user's injuries were actually caused by taking the drug.
[B] The manufacturer knew about the severe drug side effects but they failed to disclose them to the FDA and
the general public.
Users who develop one or more of the unexpected side effect(s) will likely have a viable legal claim and will be
entitled to compensation for their injuries. Families of users who have died due to the drug side effects may
also be entitled to monetary settlements for their loss. Injured patients should meet with a personal injury
lawyer for an initial consultation. During this meeting, injured patients should be able to find out if they have a
provable case against the manufacturer. Most drug lawyers work on contingency – meaning that plaintiffs
won't have to pay for legal services until (or, in some cases, unless) they win a settlement. Injured users
should consult with a lawyer to see if they can start a drug lawsuit and if it is better to file an individual lawsuit
or join a class action case.
______________________________________________________________________________
Lawsuits are being evaluated nationwide for injuries caused as a result of the following drugs: