has notified the FDA that the company will begin removing the remaining Trasylol
stock from the US.
Bayer AG is removing remaining supplies of its heart-surgery drug Trasylol
from the US market after a long-awaited study found it raised the risk of death compared to two alternatives, US regulators said.
Medicos alemanes, austriacos, italianos y norteamericanos extrajeron tejidos de los muslos o del pulmon de personas con lesiones graves sin su consentimiento y sin que lo supieran, para determinar como actuaba el Trasylol
en los tejidos y se adulteraron las tasas de mortalidad por el uso de este medicamento.
Aprotinin is marketed as Trasylol
by Bayer Pharmaceuticals in Levekusen, Germany.
The Food and Drug Administration is warning physicians that the blood-loss prevention drug Trasylol
(aprotinin injection) has been linked to higher risks of kidney problems, heart attacks, and strokes in patients who undergo coronary artery bypass graft surgery.
It is currently marketed under the name of Trasylol
by Bayer Corp.
Blood was collected, using a Vacutainer[R] system, directly into 4 tubes of each of the tube-types studied: lithium heparin with 2000 U/tube of trasylol
(L), citrate (C), EDTA (E), serum clot-activator (S), and serum separator (SST) tubes (BD Vacutainer[R] Blood Collection Tubes).
has agreed to a marketing suspension of Trasylol
, 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.
Bayer AG apologized to US regulators for withholding information about the risks of its drug Trasylol
last year, urging that the treatment used in heart bypass surgery be permitted to remain on the market.
was designed by Bayer to reduce bleeding during open-heart surgery.
The drug, aprotinin, sold under the brand name Trasylol
, is widely used to prevent or reduce blood loss during the surgery.