-Forbes

11/05/2007 - Bayer AG said it will temporarily suspend the sale of blood-clotting injection Trasylol worldwide, after a study in Canada was interrupted last month because experts said the drug exposed trial participants to an increased risk of death.

The drug will not be sold until data from the study, known as BART, is fully analysed, which may take up to eight weeks, 'or perhaps longer', the company said in a statement today.

The global halt follows orders from German regulators to suspend the marketing of Trasylol in Germany and a request from the US Food and Drug Administration to suspend marketing of the product in the US, Bayer said.

The FDA on Oct 25 said that it will re-evaluate the side effects of Trasylol, which is injected before coronary bypass surgery to prevent excessive blood loss, after the independent safety supervisors of the BART trial asked for patient enrollment to stop.

While preliminary study results indicated that Trasylol led to less serious bleeding than the two other blood-clotting drugs against which it was tested, trial patients on the Bayer drug ran a higher risk of death due to haemorrhage, the FDA said at the time.

Bayer today said an interim analysis of the interrupted BART study pointed to reduced bleeding from Trasylol but also an 'increase in all-cause mortality'.

'The totality of the available data continue to support a favourable risk-benefit profile for Trasylol when used according to label,' Bayer said in the statement today.

Trasylol generated an estimated 93 mln eur in worldwide sales in the first nine months of 2007, the company added.

Sales from the drug, which was cleared by the FDA in 1993, fell by more than a third in 2006 from 230 mln eur in 2005, the company's financial statements show.

Ennis & Ennis, P.A. is representing individuals that have been harmed as a result of Trasylol side effects. If you or a loved one have suffered as a result of Trasylol side effects such as kidney failure, heart attack, or stroke you may be entitled to compensation. For more information about a Trasylol lawsuit, a possible Trasylol recall, or for questions regarding Trasylol class action lawsuits click here for a free, confidential case evaluation.