Trasylol Lawsuit & News Blog

Bayer Has a Big Headache

Tue, 17 Jun 2008 10:09:52 -0400

Not tonight dear, Bayer has a headache, despite 2007 being a very good year for Bayer's profits and shareholders.

The bad news is that 2008 had some major setbacks. Among them is that Trasylol, a drug used in more than 33 percent of people undergoing heart surgeries are administered Trasylol. So far there are more than 200 lawsuits pending in federal courts.

According to Jim Ronca, a partner at the Philadelphia personal injury law firm Anapol Schwartz, "Now with the growing body of scientific evidence showing that the risks of Trasylol outweigh the benefits, the number of cases could increase substantially, potentially by tenfold."

A great deal of controversy follows Trasylol from the studies and findings questioning Trasylol's safety and effectiveness. Also if the FDA had removed Trasylol after the first study's findings in January 2006, instead of waiting until November 2007, some 22,000 lives could have been saved.

Other headaches for Bayer include scrapping a promising new drug that was being tested for lung cancer. The drug is approved to treat other kinds of cancer but Bayer was counting on this drug to bring in billions for lung cancer.

Also a heart medicine was pulled from the market because of intellectual property rights. It looks like 2008 is a year of wrongs. Stay tuned.

Source: Business Week

Heart Bypass Surgery Drug Causing Kidney/Renal Failure Suspended; Anapol Schwartz Attorney -- Representing Victims -- Says Situation Could Be Next Baycol

Tue, 6 Nov 2007 12:26:23 -0400

PHILADELPHIA--(BUSINESS WIRE)--According to Trasylol Lawyer, James Ronca, Esq., of law firm Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley, P.C., Bayer AG's announcement today that it would suspend sales of blood-clotting drug Trasylol, could lead to a situation in which Trasylol Lawsuits become Bayer's next Baycol. Trasylol is used in coronary artery bypass graft (CABG) procedures and found to cause kidney/renal failure.

Kidney Damage Increases with Coronary Artery Bypass Surgery

Tue, 7 Nov 2006 10:31:10 -0400

Researchers at Duke University Medical Center found that the incidence of acute kidney failure associated with coronary artery bypass surgery increased almost five-fold during the study period. The researchers estimate that approximately 20,000 cases of the kidney disorder occur nationwide each year.

How bypass surgery causes kidney damage is not exactly known but several possible causes have been suggested. Damage may be caused by alterations in blood flow that occur as a result of being placed on a heart-lung machine during surgery, or damage may occur when tiny bits of plaque break off of the walls of blood vessels, travel to the kidneys, and block its tiny blood vessels.

Drugs used during the coronary artery bypass surgery such as Trasylol also may also contribute to the phenomenon. (Duke)

Bayer Suspends Two Employees over Trasylol Data

Mon, 30 Oct 2006 12:50:59 -0400

Friday-October 13, Bayer AG suspended two senior employees over the company's failure to provide U.S. regulators with data on its heart-surgery drug Trasylol. Bayer also said it had hired an independent counsel to investigate its actions regarding the disclosure of the preliminary results from the Trasylol study.

The Food and Drug Administration began reviewing the drug earlier this year after two other studies published in medical journals linked its use to kidney problems. Bayer said it had mistakenly withheld another study based on 67,000 hospital patient records that suggested the drug could increase the chances of death, serious kidney damage, congestive heart failure, and stroke.

At the time, the Bayer said it did not share the Trasylol data with the FDA because the findings were preliminary and there were questions about the study's methods. (REUTERS)

Bayer Purposely Does Not Disclose Trasylol Dangers

Sun, 22 Oct 2006 12:51:54 -0400

Failure by the German pharmaceutical giant Bayer to inform the Food and Drug Administration of the disquieting results of a large observational study cannot be easily dismissed with an apology. Circumstances suggest that Bayer sought to hide the results and only came clean when forced to by a whistleblower.

Trasylol has long been used in heart surgery to reduce blood loss and the need for transfusions. Although extensive data seemed to document the drug's effectiveness and safety, two studies published this year found that it increased the risk of kidney failure, heart attack, and stroke.

An F.D.A. advisory committee, after reviewing extensive data at a public meeting on Sept. 21, 2006, overwhelmingly concluded that Trasylol was still acceptably safe and effective for certain patients. Bayer representatives who participated in the meeting kept quiet about the most recent Bayer-sponsored study which raised even more questions about the drug's safety.

After the fact, a whistleblower, possibly an outside researcher, reportedly called both the FDA and only then was Bayer forced to make a full disclosure. Preliminary results of the suppressed study showed that Trasylol may increase the chance for death, serious kidney disease, congestive heart failure, and strokes.

Who can you trust? (NY TIMES)

Bayer Discloses Trasylol (aprotinin) Trials Not Disclose Facts

Sun, 15 Oct 2006 08:08:46 -0400

On September 29, 2006, as reported in Yahoo, German-based Bayer acknowledged that it mistakenly did not inform the U.S. Food and Drug Administration about a retrospective study commissioned by the company to analyze the effects of aprotinin, aminocaproic acid, and tranexamic acid in patients undergoing coronary artery bypass graft (CABG) surgery. This data was not shared immediately with the FDA because it was preliminary in nature and raised significant questions on the study population, outcomes, and methodology. Bayer has submitted a copy of the preliminary Trasylol report to the FDA and has notified other regulatory authorities.

FDA Statement Regarding New Trasylol Data

Since January 2006, the FDA has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: One study reported an increase in the chance of kidney failure, heart attack, and stroke in patients treated with Trasylol compared to those treated with other similar drugs. The second study reported an increase in kidney dysfunction compared to another drug. On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database.

On September 27, 2006, Bayer Pharmaceuticals told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure, and strokes. FDA was not aware of these new data when it held the September 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.

While the FDA is conducting its study based on new Trasylol data, they recommend physicians who use Trasylol should carefully monitor patients for the occurrence of kidney, heart, or brain toxicity and promptly report observed adverse event information to the FDA MedWatch program. Physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks.

Bayer Discloses Trasylol (aprotinin) Trials Not Disclose Facts

Wed, 4 Oct 2006 14:30:29 -0400

On September 29, 2006 German-based Bayer acknowledged that it mistakenly did not inform the U.S. Food and Drug Administration about a retrospective study commissioned by the company to analyze the effects of aprotinin, aminocaproic acid, and tranexamic acid in patients undergoing coronary artery bypass graft (CABG) surgery. This data was not shared immediately with the FDA because it was preliminary in nature and raised significant questions on the study population, outcomes, and methodology. Bayer has submitted a copy of the preliminary Trasylol report to the FDA and has notified other regulatory authorities. (Yahoo)

FDA Statement Regarding New Trasylol Data

Sun, 1 Oct 2006 14:31:13 -0400

Bayer insists that Trasylol heart drug is safe

Mon, 18 Sep 2006 10:46:43 -0400

Trasylol is used to prevent blood loss during heart surgery. Manufactured by AG
Bayer, it posted a second quarter loss in sales. The decline follows two scientific studies, the first of which was published in January 2006, which linked Trasylol to higher risks of kidney problems, heart attacks, and strokes.

Bayer AG presents its data to the FDA on September 21 which could result in a change of package labeling. The first study which highlighted possible risks associated with Trasylol was published in the New England Journal of Medicine and the second in the medical journal, Transfusion. (Euro)

Trasylol (aprotinin) now proves to double a patient's risk of kidney failure

Mon, 18 Sep 2006 10:45:47 -0400

Trasylol doubles a patient's risk of kidney failure, and increases the risk of Trasylol heart attack, heart failure, stroke, and encephalopathy brain disease during coronary artery bypass surgery. Even with these known risks, Trasylol is still used in 60 percent of all surgeries.

According to the study that examined over 4,000 coronary artery bypass surgery patients at hospitals around the world, replacing Bayer aprotinin with one of two safer generic drugs would annually prevent as many as 11,050 dialysis complications, save at least $1 billion in dialysis healthcare costs, and reduce drug costs by $250 million.

The much safer generic drugs - Amicar and Cyklokapron-- cost only $11 and $44 per dose respectively. How can Bayer get away with hospitals paying $1,300 per dose for Trasylol plus being less safe? (Monheit Law)