Bayer’s Trasylol Eyed In 235 Deaths

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trasylol.jpgThat’s the latest tally from the FDA, which earlier this month convinced Bayer to suspend marketing of its controversial blood-clotting med, according to The New York Post. The agency received 235 reports “that noted death in patients who received Trasylol” to control bleeding during heart-bypass surgery from 1993, when the drug was approved, through February 2006, FDA spokeswoman Peper Long tells the paper.

The reports - from doctors, health-care providers and relatives - do not necessarily prove Trasylol killed the patients, she notes. Long also couldn’t provide The Post with the number of deaths over the past 19 months - when such reports were expected to jump following several studies warning the drug could cause kidney damage, stroke and heart failure. Adverse event reports usually spike following increased publicity over problems with a drug.

The FDA acted this month after a detailed review of preliminary results from a Canadian study suggested an increased risk for death among Trasylol patients. The Data Safety Monitoring Board for the trial of 3,000 Canadian surgery patients recommended halting that study after early findings pointed to a greater chance of dying compared with two other drugs. This is the FDA statement and this is the Bayer statement.

Trasylol has a tortured history. A year ago, an FDA panel met to review data showing Trasylol was linked to a higher risk of death, kidney failure, congestive heart failure and stroke. The panel declared Trasylol was safe and effective, and voted unanimously to keep the med on the market. But a few days later, the FDA was contacted by a Bayer consultant at Harvard’s School of Public Health, who said Bayer hid evidence. He was hired by Bayer six months earlier to review a 67,000-patient database and compare Trasylol side effects with two other anti-bleeding drugs. A warning was placed on the product label and usage was limited to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery

But the disclosure caused a furor, especially after it became known that Bayer employees failed to notify the FDA of the study, which showed that Trasylol can increase risk of death, kidney damage, heart failure and stroke. To clear its name, Bayer hired an outside lawyer to investigate. And this summer, prior to the latest FDA panel meeting, the drugmaker insisted the cover-up was no cover-up, but merely a misunderstanding by two employees.

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