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

Zero accountability for drug companies?

Bloomberg recently ran an article about pharmaceutical companies enjoying their “get out of jail free cards” — revisions to regulations that favor the rights of pharmaceutical companies over consumers who use their drugs. The revised regulations, written just after George W. Bush’s second inauguration in 2005, allow federal law to trump state law, thereby clearing the path for drug manufacturers to develop, test, market, and essentially do business with impunity from the law.

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Bloomberg recently ran an interesting and comprehensive article about pharmaceutical companies enjoying their “get out of jail free cards” — revisions to regulations that favor the rights of pharmaceutical companies over consumers who use their drugs. The revised regulations, written just after George W. Bush’s inauguration in 2005, allow federal law to trump (or pre-empt) state law, thereby clearing the path for drug manufacturers to develop, test, market, and essentially do business with impunity from the law.

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The Food and Drug Administration sent Bayer Health Care official warnings, stating that the company is marketing and selling two over-the-counter medications that are “illegal,” according to FDA spokeswoman Rita Chappelle.

The two aspirin products, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, are misbranded, mislabelled, and confusing to consumers, according to the FDA.

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Two Illinois residents have filed suit against Bayer, claiming that Trasylol injections led to acute renal failure and other problems in one case and death in the other.

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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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originally used to reduce bleeding during complicated surgery, trasylol was recalled by manufacturer Bayer in 2007 and permanently withdrawn in 2008

On January 26, 2006, The New England Journal of Medicine (NEJM) published an article by Mangano et al. reporting an association of Trasylol (aprotinin injection) with serious renal toxicity, myocardial infarction and stroke in patients undergoing coronary artery bypass grafting surgery.

On February 8, 2006, the Food & Drug Administration (FDA) issued a Public Health Advisory noting that it was evaluating the NEJM study, along with other studies and adverse affect reports submitted through its MedWatch voluntary reporting program. Physicians were advised to carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or to the FDA MedWatch program. Physicians also were advised to limit Trasylol use.

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, a Bayer worldwide safety review, and the FDA review of its own post-marketing database, and made recommendations for labeling changes.

FDA announced on September 29, 2006, that Bayer informed the agency of an additional safety study on September 27, 2006.  The preliminary results from that study suggest that in addition to serous kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes.

In a Public Health Advisory Update dated October 3, 2006, the FDA recommended that “physicians consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is necessary to medical management and outweighs the potential risks” and carefully monitor patients.

On October 29, 2006 the Food and Drug Administration issued a warning that aprotinin may have serious kidney and cardiovascular toxicity. The producer, Bayer, reported to the FDA that additional observation studies showed that it may increase the chance for death, serious kidney damage, congestive heart failure and strokes.

December 15, 2006, the FDA approved revised labeling for Trasylol (aprotinin injection) to strengthen its safety warnings and to limit its approved usage to specific situations. The labeling changes for Trasylol are based on the recommendations of the September 2006 advisory committee.

On November 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol. At that time, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.

On May 14, 2008, the FDA announced Bayer had removed all remaining stocks of Trasylol from distribution in the U.S., and would limit access to the product to investigational use. The limited use agreement protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.

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.

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.

A conclusive study of Bayer AG’s aprotinin injection Trasylol uncovered a grim fact: one out of every 50 Trasylol recipients dies. The study was conducted in Canada and involved monitoring the health of 2,331 high-risk heart patients.

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The FDA announced today that Bayer Pharmaceuticals Corp. will begin removing all remaining supplies of the drug Trasylol (aprotinin) from warehouses and other medical stock. The decision comes following the preliminary results of a test that showed the drug greatly increased the risk of death. Trasylol is administered to patients undergoing heart surgery to slow bleeding and reduce or eliminate the need for blood transfusions.

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