(NaturalNews) Pharmaceutical giant Bayer AG has announced that it is withdrawing its drug Trasylol from the market in response to a request by the FDA, in the face of increasing evidence that the drug increases patients' risk of death.
"[The] FDA could not identify a specific patient population where the benefits of using Trasylol could outweigh the risks," an agency official said.
Trasylol, known by the generic name aprotinin, is given to patients before major heart surgeries in order to reduce bleeding. It was first approved by the FDA in 1993, and is prescribed to approximately 200,000 patients per year, 55 percent of those in the United States.
The FDA's request to Bayer came after the early abortion of a study by the Ottawa Health Research Institute, when researchers discovered that heart bypass and valve surgery patients given Trasylol were 50 percent more likely to die than patients not given the drug, even though they experienced less bleeding.
The study was halted early out of concern for the lives of other participants. Because of the early conclusion, however, researchers still do not know why taking Trasylol increases a patient's risk of dying.
Prior studies have also indicated that Trasylol is a risky drug. A 2006 study in the "New England Journal of Medicine" found that Trasylol is responsible for 10,000 to 11,000 cases of kidney failure each year, in addition to heart attacks and strokes. Another study, conducted by Bayer and initially concealed from the FDA, found that taking the drug increased the risk of stroke and death.
Because many doctors are used to prescribing Trasylol as a matter of course before heart surgeries, the FDA anticipates that phasing the drug out will be difficult. Two FDA panels convened after reports of health risks first surfaced and both concluded that the drug should remain on the market; only after the Canadian study results emerged did the agency ask Bayer to withdraw the drug.
In response to the same study and in contrast to the FDA's request for voluntary removal, German health regulators withdrew Trasylol's approval immediately.