Menu

FDA Alerts

Subject: FDA- MedWatch- Aprotinin Injection (marketed as Trasylol)

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
Subject: FDA- MedWatch- Aprotinin Injection (marketed as Trasylol)- Patient Enrollment In The Aprotinin Treatment Group Arm of BART Study Stopped

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA informed healthcare professionals of the Data Safety Monitoring Board's 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.

Read more: Subject: FDA- MedWatch- Aprotinin Injection (marketed as Trasylol)

FDA MedWatch: Trasylol (aprotinin injection)

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
FDA MedWatch: Trasylol (aprotinin injection) - FDA requests marketing suspension and Bayer Pharmaceutical Corp. has agreed, pending a detailed review of preliminary results from a Canadian study that suggested an increased risk for death

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA announced that, at the agency's 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 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.

Read more: FDA MedWatch: Trasylol (aprotinin injection)

Updated Warfarin (Coumadin) labeling includes new genetic information

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
FDA - MedWatch - Updated Warfarin (Coumadin) labeling includes new genetic information that may help providers improve initial dosing estimates of anticoagulant for individual patients

Read more: Updated Warfarin (Coumadin) labeling includes new genetic information

Baxter Healthcare Corp. and FDA notified healthcare professionals

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
FDA - MedWatch - Baxter Healthcare Corp. and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163.

Read more: Baxter Healthcare Corp. and FDA notified healthcare professionals

Merck Recalls 3 Lots Of Invanz

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
FDA - MedWatch - Merck Recalls 3 Lots Of Invanz (ertapenem sodium) Injection Because The Product May Contain Broken Glass Pieces In The Reconstituted Solution For Injection

Read more: Merck Recalls 3 Lots Of Invanz

Amount: 

Color I Color II Color III

Log In or Register