May 14, 2008
On May 14, 2008, Bayer HealthCare Pharmaceuticals Inc. announced that it was voluntarily removing Trasylol, a drug given during heart surgery to control bleeding, from the market. Compared to two other drugs used to control bleeding, Trasylol may significantly increase the risk of death.
Although Trasylol sales have been suspended since November 2007, doctors were still administering Trasylol to patients from existing supplies. Now, Bayer has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock.
After the FDA approved Trasylol in 1993, the drug was used in about one third of all cardiac bypass operations in America. Even though a 2006 study showed widespread death associated with Trasylol, Bayer continued to aggressively market the drug until 2007, when the FDA asked Bayer to suspend Trasylol from the market.
During the 14 years that Trasylol was on the market, it may have contributed to thousands of deaths. In fact, up to 22,000 patients’ lives could have been saved if Bayer had removed Trasylol from the market in 2006, when studies revealed the drug’s danger. This figure comes from a renowned researcher who estimates that Trasylol may have contributed to the deaths of 1,000 surgery patients each month over the last two years.
As it turns out, there was concern about Trasylol’s safety long before the 2006 study. In the early 1980′s, Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe kidney damage in animals given Trasylol. Although he told Bayer about his findings, Dr. Fischer stated, “I felt that Bayer wasn’t interested to examine these side effects.”
Soon, American doctors started noticing adverse side effects in humans given Trasylol. “The most common problem we saw was renal failure. That is, that kidneys did not function properly after surgery,” says the Missouri Baptist Medical Center’s Dr. Nicholas Kouchoukos, one of the U.S.’s top heart surgeons. In addition to kidney failure, doctors documented heart attacks and strokes associated with Trasylol.
All together, more than 4.77 million patients have received Trasylol since it was released on the market in 1993. In 2006 alone, approximately 110,000 U.S. patients and 87,000 patients outside of the U.S. received Trasylol. If you or a loved one were given Trasylol and experienced serious complications, such as kidney failure, heart attack, or stroke, contact us today to learn more about your legal rights and options.
