Bayer says temporarily suspends Trasylol marketing

FRANKFURT(Reuters) - Germany's Bayer AG has suspended temporarily the global marketing of its anti-bleeding drug Trasylol, which has been linked to a higher risk of death, pending final results of a Canadian study on the medicine.

Trasylol is aimed at preventing blood loss in patients with an increased risk for blood loss during heart bypass surgery.

The drug, approved in 1993 and known generically as aprotinin, has been under a cloud for more than a year amid data suggesting it might boost the risk of death, serious kidney damage and stroke, so the step was not unexpected.

Bayer said in a statement Monday that the decision followed requests from German, U.S. and other regulators for the company to suspend the drug until final BART study data were available.

The BART study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients.

Trasylol global sales in the first nine months of 2007 were around 93 million euros, including about 63 million euros from the United States and 5 million euros in Germany.

Bayer shares gained 0.6 percent to close at 57.01 euros in German trading.

Bayer is set to release its quarterly results on Tuesday.

"Once the complete BART dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol," Bayer said.

In October, recruitment for the BART trial was halted following safety concerns linked to the treatment.

The U.S. Food and Drug Administration said at that time that the 30-day mortality risk in the Trasylol group in the trial was nearing statistical significance, compared with other treatments it was tested against. The drug was linked to less serious bleeding but more deaths due to hemorrhage in an initial analysis.

On Monday, Bayer said it had been informed that BART trial data were now being collected from centers throughout Canada and final data analysis would emerge in around eight weeks.

"Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling," the company said.

The FDA said it was working with Bayer to slowly phase out Trasylol without creating a shortage of alternative drugs.

"Until FDA can review the data from the terminated study, it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits outweigh the risks," an FDA statement said.

"Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol," the agency added.

In September, an FDA panel recommended the drug stay on the market despite its risks but urged the company to conduct a randomly controlled clinical trial, a rigorous study that is considered the gold standard for evaluating a drug.

Analysts' expectations for Trasylol had been low.

"We believe even the worst-case scenario of a product withdrawal from all markets would have a negligible effect on our forecasts," said Richard Vosser, an analyst at Bear, Stearns, in a note last month.

"Given the previous positive recommendations on risk/benefit, unmet medical need of the patients and the limited size of the product, we also view the risk of litigation as low," he added.

Bayer had previously said it mistakenly withheld a study of 67,000 hospital records suggesting Trasylol might boost the risk of death, kidney damage, congestive heart failure and stroke. (Additional reporting by Lisa Richwine in Washington)