Personal Injury Law

FDA Suspends Marketing of Trasylol

By Louthian Law Firm

Trasylol, a defective drug manufactured by Bayer AG, may have claimed as many as ?1,000 lives per month? in the time before it was recalled, according to a doctor who presented a study to the FDA in September 2006. It wasn?t until November 2007, however, when the Canadian Data Safety Monitoring Board had stopped a Trasylol trial after a data analysis indicated that the 30-day mortality risk in the study?s patients was nearing ?statistical significance?, that Bayer suspended sales of the drug in the US at the FDA?s request.

Trasylol is a drug used to prevent bleeding during heart bypass surgery, and before it was removed from the market, about a third of all bypass patients had received Trasylol. The initial reports from the Canadian study suggested an increased risk of death for Trasylol users compared with two other antifibrinolytic drugs. There had also been reports linking Trasylol with kidney problems, amputations, heart attacks and strokes.

Dr. Dennis Mangano, who presented his study to the FDA which found that Trasylol increased the risk of kidney failure requiring dialysis, as well as death, believes Trasylol should have been taken off the market when he published his study in 2006. Bayer executives, in fact, attended Mangano?s presentation in order to defend Trasylol. What they did not tell the FDA was that their own Trasylol study, known as the 13 drug report, confirmed Mangano?s findings. That study, which analyzed a database of hospital patients who were given the drug, suggested the drug?s use could also increase the likelihood of serious kidney damage, congestive heart failure and strokes. Even after learning about the 13 drug report, however, the FDA allowed Trasylol to remain on the market, adding only a warning label to its packaging explaining that the drug placed patients at high risk of kidney failure. Between the study?s publication and November 2007 when Bayer removed Trasylol, close to half a million patients received the drug.

Full post as published by South Carolina Lawyer Blog on February 18, 2008 (boomark / email).