| TRASYLOL | | Health Canada | 15-May-08 | OTTAWA - In light of the May 14, 2008 publication in the New England Journal of Medicine of the BART study on the use of Trasylol (the brand name for aprotinin) during high-risk cardiac surgery, Health Canada would like to update Canadians on the status of Trasylol in Canada.
A limited access program was put in place by Bayer, in consultation with Health Canada, to make Trasylol available to physicians who conclude that the benefits outweigh the risks for patients undergoing CABG surgery.
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| TRASYLOL | | FDA | 14-May-08 | Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.
Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol.
The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy.
FDA announced that, at the agencys request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection), a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
FDA has not yet received full study data but expects to act quickly with Bayer, the studys 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.
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.
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| TRASYLOL | | MHRA | 03-Dec-07 | MHRA has issued drug updates:
Recombinant human erythropoietins: new prescribing advice
Rosiglitazone and pioglitazone: cardiovascular safety
Dosulepin: measures to reduce risk of fatal overdose
ACE inhibitors and angiotensin II receptor antagonists: not for use in pregnancy
Short-acting ß agonists: myocardial ischaemia
Varenicline: possible effects on driving, and psychiatric illness*
NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
Aprotinin: suspension of Marketing Authorisations
Lumiracoxib: suspension of Marketing Authorisations
Strontium ranelate: risk of severe allergic reactions
Talc for pleurodesis: risk of adverse events |
| TRASYLOL | | FDA | 05-Nov-07 | FDA informed healthcare professionals of the Data Safety Monitoring Boards recommendation to stop patient enrollment in the aprotinin treatment group arm of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study.
The BART study was designed to test the hypothesis that aprotinin was superior to epsilon-aminocaproic acid and tranexamic acid in decreasing the occurrence of massive bleeding in association with cardiac surgery.
The preliminary findings suggest that, compared to the antifibrinolytic drugs, epsilon-aminocaproic acid and tranexamic acid, aprotinin increases the risk of death.
FDA anticipates re-evaluation of the overall risks and benefits of Trasylol which may result in the need to revise the prescribing information or other regulatory actions.
Healthcare professionals who are considering use of Trasylol should be aware of the risks and benefits described in the prescribing information for Trasylol and the accumulating data suggesting Trasylol administration increases the risk of death compared to other antifibrinolytic drugs.
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| TRASYLOL | | FDA | 05-Nov-07 | Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.
Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol.
The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy.
FDA has not yet received full study data but expects to act quickly with Bayer, the studys 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.
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.
However, 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.
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| TRASYLOL | | Health Canada | 05-Nov-07 | OTTAWA - At the request of Health Canada, the manufacturer Bayer Inc. has temporarily suspended marketing of the drug Trasylol (aprotinin), pending a review of preliminary results from a clinical trial (the BART study) that suggested an increased risk of death.
Health Canada has been reviewing post market safety information for Trasylol and is actively evaluating the safety profile of this product.
This evaluation will include examining the relevant findings from the clinical trial and an evaluation of the risks and benefits associated with the use of Trasylol.
Health Canada will continue to communicate information and recommendations related to this product to health professionals and the public.
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| TRASYLOL | | Health Canada | 30-Mar-07 | The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties.
This is duplicated text of a letter from Bayer Inc. Contact the company for a copy of any references, attachments or enclosures.
Trasylol® is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in those patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) surgery who are at increased risk for blood loss and blood transfusion requirement.
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