Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

A report released yesterday underlines the danger of Trasylol (aprotinin), which was used for years to limit bleeding during surgery. Trasylol was taken off the market last year after U.S. tests indicated the drug posed a significantly higher risk of death as opposed to other anti-bleeding drugs.

The new study, as reported by Forbes.com, includes an examination of Trasylol use in 49 randomized clinical trials, and also includes new information from the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study, published earlier this year. The findings of the new study, which was conducted by Canadian and Australian reserachers, will be published in the Jan. 20 issue of the Canadian Medical Association Journal.

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In September 2006, Bayer Pharmaceuticals, manufacturer of Trasylol (aprotinin), was faulted by the FDA for not revealing during testimony the existence of a commissioned retrospective study of 67,000 patients, 30,000 of whom received aprotinin and the rest other anti-fibrinolytics. The study concluded aprotinin carried greater risks. The FDA was alerted to the study by one of the researchers involved.

Trasylol was approved in 1993 in the United States to reduce bleeding during open-heart surgery.

The sale and use of Trasylol, manufactured by Bayer, was halted in 2007 after two studies published in the New England Journal of Medicine in 2006 indicated the drug raises the risk of kidney damage and death.

One of the research studies, both of which were published in January 2006, linked the drug to renal toxicity, myocardial infarction and stroke, and the other suggested the drug might increase the possibility of kidney damage, although it didn’t include increased risk of heart attack or stroke. The reports triggered a safety review by the Food & Drug Administration (FDA), which on Feb. 8, 2006, issued a Public Health Advisory about the findings of the study.

There were subsequent investigations of Trasylol conducted by the FDA, which convened a Cardiovascular and Renal Drugs Advisory Committee on September 21, 2006. The committee reviewed findings from the two previously published studies, along with a Bayer worldwide safety review, and the FDA’s own post-marketing database, which compiles voluntary adverse effect reports submitted by individuals and health care providers through the MedWatch program.

As a result of the meeting, the FDA recommended labeling changes for the drug, carrying stronger warnings.

However, it was not until a week later that Bayer informed the FDA of the results of another safety study it had conducted, which indicated even more serious side effects of Trasylol, including death, congestive heart failure and strokes.

An investigation revealed that a Bayer researcher was hired six months prior to the FDA committee meeting to review a 67,000-patient database to compare Trasylol side effects with those of other anti-bleeding medications, revealing Trasylol’s more serious side effects as compared to the other medicines.

According to Official Report on Traysol prepared for Bayer Corporation by Zuckerman Spaeder LLP, and independent investigator, in August 2006, Bayer did not disclose the findings and conclusions from the report before or during the Sept. 21 FDA advisory committee meeting because Bayer’s doctors had questions about the study’s quality and so considered disclosure of the results “scientifically premature.”

While there has been no real repercussion, either from the FDA or any other source, for Bayer’s withholding of this information, in an Bayer statement about Traysol study dated August 16, 2007, the company said the decision to withhold the information was “a serious error of judgment.” The company said it analyzed its drug safety and monitoring procedures as a result, and would work to strengthen its “already strong structures and rigorous processes.”

Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.

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Trasylol is a medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery

Trasylol (aprotinin), manufactured by Bayer, is a protein that is used as medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery. Its main effect is the slowing down of fibrinolysis, the process that leads to the breakdown of blood clots. The purpose of Trasylol is to decrease the need for blood transfusions during surgery, as well as end-organ damage due to hypotension (low blood pressure) as a result of marked blood loss.

Bayer withholds critical information

In September 2006, Bayer Pharmaceuticals was faulted by the FDA for not revealing during testimony the existence of a commissioned study of Trasylol that concluded Trasylol carried greater risks. The FDA was alerted to the study by one of the researchers involved.

Trasylol recall

The drug was temporarily withdrawn worldwide in 2007 after studies suggested that its use increased the risk of complications or death; after this was confirmed by follow-up studies, Trasylol was entirely and permanently recalled in May 2008, except - at least for the time being - for very restricted research use.

Do you have a trasylol claim?

If you or your loved one has suffered a serious injury or death as a result of trasylol, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our trasylol lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.

Beasley Allen law firm is actively pursuing Trasylol recall and Trasylol death claims in all 50 states

Our defective drug and product liability lawyers work solely on behalf of individual plaintiffs that were injured by defective products, such as heparin.

Over the past 29 years, we have successfully handled these types of claims, having recovered more than $20 billion in verdicts and settlements for our clients.

Frank Woodson is the Trasylol lawyer investigating claims on behalf of the firm.

Do you have a trasylol claim?

If you or your loved one has suffered a serious injury or death as a result of trasylol, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our trasylol lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.

The FDA in conjunction with Bayer Pharmaceuticals, has recalled Trasylol, after results showed an increased risk of death

On May 14, 2008, Bayer HealthCare Pharmaceuticals Inc. 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. The FDA has agreed to work with Bayer to ensure a smooth and complete process.

FDA limits access to certain drugs to patients with serious or immediately life-threatening disease or conditions who lack other therapeutic options and may benefit from such therapies.

The Trasylol recall comes after a randomized Canadian study that prompted last November’s marketing suspension of Trasylol are expected to be published this week. The data contained in this article suggest that Trasylol appears to increase the risk for death compared to two other antifibrinolytic drugs used in the study.

Do you have a trasylol claim?

If you or your loved one has suffered a serious injury or death as a result of trasylol, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our trasylol lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.