Navigation Links
FDA to Review Clotting Drug After Trial Suggests Death Risk
Date:10/25/2007

Findings come as another blow to Trasylol, used to cut down on bleeding during cardiac surgery

THURSDAY, Oct. 25 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday said it will review the safety of the clotting drug aprotinin (Trasylol), after a major Canadian trial was stopped early due to an increase in deaths for cardiac surgery patients placed on the drug.

Trasylol, first approved by the FDA in 1993, is typically used to limit blood loss in patients undergoing cardiac surgery.

While less bleeding was noted in the aprotinin group versus patients assigned one of two other drugs, "a trend toward increased mortality in the aprotinin group had been observed throughout the study," the FDA noted in a statement released Thursday.

That elevated 30-day and overall death risk caused the Canadian study's Data Safety Monitoring Board (DSMB) to recommend stopping patient enrollment in the so-called BART trial. The trial was set to recruit about 3,000 adults who were candidates for a variety of cardiac surgeries and were at high risk of bleeding.

"The DSMB concluded that continued enrollment of patients into the aprotinin group was unlikely to significantly change the study findings," the FDA said.

Trasylol's maker, Bayer, also issued a new "guidance" to doctors on Thursday. The German company advises "that physicians use Trasylol only in accordance with approved product labeling." Bayer said it believes the drug "remains a safe and effective treatment option for physicians," but it is working with the FDA and international health authorities to see if any label changes might become necessary as new data emerges.

Trasylol has had a checkered history since it was first approved by the FDA in 1993.

On Sept. 12, a U.S. Food and Drug Administration advisory panel recommended that aprotinin remain on the market, despite evidence that it might have serious side effects.'/>"/>

Copyright©2007 ScoutNews,LLC.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. FDA may speed review of new drugs
2. Scientists review SARS
3. US Reviews Risks Of Tamiflu After 12 Children Die
4. Breast Cancer Examinations To Be Reviewed In Irish Hospitals
5. BioCryst’s Bird Flu Drug Enjoys Fast-Track Review By FD
6. A Sneak Preview of Human’s Susceptibility to Auto Immune Disease, Allergy, Asthm
7. Thumbs up in weight loss for vegetarian diets: scientific review
8. FDA Accords Priority Review For Pediatric Crohns Disease Drug
9. The Lancet Calls For Review Of Regulatory Process Of Drug Trials
10. Review of Pramod Mahajans Injuries
11. Vaticans Council Reviews Condom Usage
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... THURSDAY, July 10, 2014 (HealthDay News) -- Nature, not ... intelligence of individual chimpanzees, a new study finds. ... it comes to cognitive [thinking] abilities in chimpanzees," William ... Atlanta, said in a news release from the journal ... give insight into the evolution of intelligence in humans, ...
(Date:7/10/2014)... July 10, 2014 (HealthDay News) -- Men who have ... prostate cancer, a new study suggests. But the ... urologists not involved with the study said more research ... truly accurate. For the study, Harvard researchers analyzed ... followed for 24 years, starting in 1986. During that ...
(Date:7/10/2014)... than 200 experts on aggression, who research issues ranging ... the 21st World Meeting of the International Society for ... July 15-19. , Georgia State University is hosting the ... on alternating continents. , "We are excited to be ... countries, which will help produce fresh ideas about the ...
(Date:7/10/2014)... CLEVELAND The U.S. Department of Health and Human ... Hospitals (UH) Case Medical Center Seidman Cancer Center totaling ... at improving care for patients with complex cancer. ... a unique model developed at UH to enhance care ... or demonstrated need for high health care utilization. ...
(Date:7/10/2014)... studies have shown that more severe illness and even ... secondary respiratory infection after developing influenza. Now, however, a ... determined that if you reverse the order of infection, ... may actually protect against a bad case of the ... protein pneumolysin, which is described as a bacterial virulence ...
Breaking Medicine News(10 mins):Health News:Like Humans, Chimps' Smarts May Rely on Genes 2Health News:Study Links Vasectomy to Aggressive Prostate Cancer 2Health News:Study Links Vasectomy to Aggressive Prostate Cancer 3Health News:Georgia State hosts national conference on aggression 2Health News:Georgia State hosts national conference on aggression 3Health News:UH Case Medical Center awarded $4.7 million grant from HHS 2Health News:UH Case Medical Center awarded $4.7 million grant from HHS 3Health News:Bacterial colonization prior to catching the flu may protect against severe illness 2
... Caraco Pharmaceutical,Laboratories, Ltd. (NYSE Alternext US: CPD) posted net ... first nine months of Fiscal 2009 of $55.7,million and ... million, respectively, for the third quarter and first nine ... the third quarter of Fiscal 2009,and an increase of ...
... study, presented at The Endocrine Society,s 90th Annual Meeting ... carbohydrates and protein followed by a low-carb, low-calorie diet ... dieters on track with their weight loss program.Lead author, ... Venezuela, along with scientists from Virginia Commonwealth University ...
... division of Ben Venue Laboratories, Inc., announced the ... AP rated and is equivalent to Camptosar(R).,Irinotecan is ... colon or,rectum whose disease has recurred or progressed ... for immediate shipment,nationwide. , ...
... RediClinic LLC today announced that it,has expanded its ... of Texas to include its Austin area clinics. ... an in-network provider for Blue Cross Blue,Shield enrollees. ... in,the Austin area and 15 H-E-B stores in ...
... 117 studies and 25,000 patients to arrive at ranking ... and escitalopram (Lexapro) are the best of 12 new-generation ... analysis shows. , The Italian researchers reviewed 117 studies ... to come to this conclusion. , The drugs tested ...
... First Substantive Legislation that would provide Comprehensive Pancreatic ... ProgressEL SEGUNDO, Calif., Jan. 29 The Pancreatic ... hope in a comprehensive way through research, patient ... applauds U.S. Representatives Anna Eshoo (D-CA) and Ginny ...
Cached Medicine News:Health News:Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009 2Health News:Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009 3Health News:Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009 4Health News:Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009 5Health News:Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009 6Health News:Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009 7Health News:Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009 8Health News:Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009 9Health News:Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Third Quarter and First Nine Months of Fiscal 2009 10Health News:New Study: Protein in the Morning Helps Dieters Stay on Track and Keep Weight Off 2Health News:Bedford Laboratories(TM) to Begin Shipping Irinotecan HCl Injection 2Health News:RediClinic Locations in Austin Added as Blue Cross and Blue Shield of Texas Network Providers 2Health News:Zoloft, Lexapro the Best of Newer Antidepressants 2Health News:The Pancreatic Cancer Research and Education Act Addresses the Astounding Mortality of the Fourth Leading Cause of Cancer Death in the United States 2Health News:The Pancreatic Cancer Research and Education Act Addresses the Astounding Mortality of the Fourth Leading Cause of Cancer Death in the United States 3
(Date:7/10/2014)... 11. Juli 2014  Dilon Technologies, ... die molekulare Bildgebung, einschließlich molekularer Bildgebung ... CE-Zulassung für sein Navigator ® -Gamma-Sondensystem ... das Produkt jetzt europaweit vertreiben. Dilon ... der europäischen Länder ausgedehnt und bereits ...
(Date:7/10/2014)... July 10, 2014  The U.S. Department of Health ... to University Hospitals (UH) Case Medical Center Seidman Cancer ... model aimed at improving care for patients with complex ... project will test a unique model developed at UH ... disease, significant comorbidities, or demonstrated need for high health ...
(Date:7/10/2014)... , July 10, 2014  Breg, Inc., ... services, has launched the FreeRunner™ knee brace with ... suffer from patella mal-tracking return to active lifestyles. ... than other braces, providing support when patients need ... when they don,t. Patellofemoral issues are ...
Breaking Medicine Technology:Dilon erhält CE-Zulassung für sein Navigator-Gamma-Sondensystem 2University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 2University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 3University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 4Breg Introduces Knee Brace to Help Runners with Patellofemoral Pain Syndrome 2