| |
Trasylol health risks: kidney failure, heart attack, stroke, and death |
| |
A study published in January 2006 and supplemented February 2007 helps to quantify the health risks of Trasylol: a 50% increased risk of heart attack, 181% increased risk of stroke, and a nearly doubled risk of renal failure, and 30% increased risk of death compared to patients on aminocaproic or tranexamic acids. In September 2006, Dr. Dennis T. Mangano, presented these results to a Food and Drug Administration (FDA) panel, but the FDA did nothing but add information to a warning label in December 2006.
Even after it was revealed that a study conducted by Bayer AG itself had confirmed Mangano's results, a second FDA advisory panel convened in September 2007 and decided that Trasylol ought to remain on the market, advising only that doctors monitor patients' health more carefully. It was not until a separate Canadian study was halted due to an increased death rate among participants taking Trasylol that the FDA requested the gradual withdrawal of the drug from US markets in late 2007.
In February 2008, Dr. Mangano faulted Bayer AG for failing to disclose its study results earlier and the FDA for failing to act quickly. He estimated that the delay in removing Trasylol from the market carried a price of nearly 22,000 lives, or nearly 1,000 lives every month.
|
