Coronary bypass patients that were given the drug Aprotinin, sold under the brand name of Trasylol, should be aware that the product has been linked to kidney failure, heart attacks and strokes -- and implicated in thousands of deaths.

First introduced in 1993, Trasylol was approved by the Food and Drug Administration to prevent blood loss during surgery. The initial use was for patients who were at a high risk for bleeding during coronary artery bypass procedure. But in 1998, the FDA expanded its approval to cover all heart bypass patients.

The drug’s sales and usage soared under that expanded approval. By 2005, annual sales hit the $300 million mark. That same year, 245,000 patients were given the drug. Numbers from the drug’s manufacturer, Germany’s Bayer AG, indicate that more than one million patients have taken Trasylol in the drug’s 15-year history.

Trasylol came under intense scrutiny in February 2006 when the FDA issued a Public Health Advisory alerting doctors that the drug had been linked to higher risks of serious side effects. That advisory came on the heels of two scientific studies, including one published in the New England Journal of Medicine, which reported that Aprotinin doubled the risk of kidney damage and increased the risk of heart attack by 48 percent in comparison to other alternatives. The risk of stroke jumped by 181 percent, one report found.

Bayer AG, bowing to pressure from the FDA, agreed to suspend Trasylol sales in November 2007. In February 2008, CBS news reported that as many as 22,000 deaths – 1,000 per month -- could have been prevented if Trasylol had been taken off the market in January 2006, when questions about the drug’s serious side effects were widely publicized.

Meantime, two new studies released in February 2008 have confirmed the earlier concerns about Trasylol’s dangers.

One study examined 10,000 patients who underwent coronary artery bypass surgery. The death rate among 1,343 people who took Trasylol was 32 percent higher than in patients who were not given any medication to control bleeding. Also, the death rate for patients taking Trasylol was 27 percent higher than for patients who received aminocaproic acid, another medication for controlling bleeding.

The second study, led by doctors at Harvard Medical School, looked at 78,000 coronary bypass surgery cases and compared how patients had fared when either Trasylol or aminocaproic acid was given. About 33,500 patients in the study received Trasylol; about 45,000 took aminocaproic acid. The risk of death was 64 percent higher for patients in the Trasylol group. The doctors also found that patients who took Trasylol were more likely to need dialysis, a procedure used to clean the blood in cases of kidney failure.

Younce & Vtipil is devoted to assisting people who have suffered serious Trasylol side effects. If you or a loved one has experienced a heart attack, stroke, kidney damage or death while using Trasylol, you should contact an experienced Trasylol lawyer to discuss your legal rights.

At Younce & Vtipil, it will cost you nothing to speak with an attorney about your potential claim and there is no obligation when you call. We are typically paid on a contingent fee basis, meaning that we are not paid until we successfully obtain money for our client. If we can be of service to you, your family or friends, please do not hesitate to call us at 1-800-811-9495 or contact us online.