(223) The MDL involving the drug Trasylol
, centralized in the Southern District of Florida, embraced direct filing and applied Florida choice-of-law rules to all cases filed there, regardless of the home states of the parties.
We collected 2 mL of amniotic fluid into sterile containers containing 5000 kallikrein inhibitor units of aprotinin (0.2 mL Trasylol
Human cancer cell lines and drug-resistant sublines (Table 1) were grown in Leibovitz L-15 medium (Biowhittaker, Walkersville, MD) supplemented by 10% fetal calf serum (FCS) (GIBCO/BRL, Grand Island, NY), 1 mM L-glutamine, 6.25 mg/1 fetuin, 80 IE/1 insulin, 2.5 mg/ml transferrin, 0.5 g/1 glucose, 1.1 g/1 NaHCO3, 1% minimal essential vitamins and 20,000 kIE/1 trasylol
in a humidified atmosphere of 5% [CO.sub.2] at 37 [degrees]C.
hired a CRO to test its drug Trasylol
, which was given to patients before surgery to reduce the risks of blood loss.
In preclinical testing, Textilinin has compared favourably to other antifibrinolytic products such as Trasylol
(aprotinin), a product used to reduce perioperative blood loss in patients undergoing coronary artery bypass graft surgery (CABG).
In 2008, cancer drug Nexavar achieved 76% growth, offsetting the drop in hematology/cardiology sales (-13%), impacted by the suspension of Trasylol
back in November 2007.
They cite the withdrawal of Vioxx, Trasylol
, fen-phen, and Redux from the market as examples of the pharmaceutical industry's failure to adequately warn consumers of drug hazards even when the manufacturers knew of the risks.
Among them were Zelnorm, Exubera, Trasylol
, Pergolide and Premax--none of them blockbusters for sure, but all with significant sales and more significant potential had they proven safe and effective post approval.
* Aprotinin (Trasylol
), used to reduce bleeding in coronary artery bypass operations for the last 15 years, probably does more harm than good (Schneeweis et al., NEJM 2008; 358: 771-783).
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.
In her New England Journal of Medicine article, Shuchman described how hazardous side effects nearly fell through the cracks in a postmarketing safety study involving aprotinin (Trasylol
), an antifibrinolytic drug made by Bayer.