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Trasylol 10 articles

Follow-up to Canadian BART study confirms Trasylol risks

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, ... Read More

Pre-emption could give Bayer an escape from Trasylol case

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. Think corporate Utopia. Think David vs. Goliath where Goliath enjoys a major handicap. According to the U.S. Constitution, any decision to pre-empt ... Read More

Zero accountability for drug companies?

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. Think corporate Utopia. Think David vs. Goliath where Goliath enjoys a major handicap. According to the U.S. Constitution, any decision to pre-empt state ... Read More

FDA warns Bayer about two OTC aspirin products

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. According to Bayer, its Women’s Low Dose Aspirin fights heart disease and osteoporosis with a combination of 81 mg of aspirin and the equivalent of an 8-oz glass of milk in calcium for possible “lifesaving benefits.” Bayer Heart Advantage combines the same ... Read More

Two suits filed against Bayer in Illinois

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. Both complaints were filed in the St. Clair County Circuit Court. Gary Harms received a Trasylol injection in 2005 while he was undergoing heart surgery at Des Peres Hospital in St. Louis, Missouri. He has since suffered from acute renal failure and requires regular dialysis to perform the functions of his failed kidneys. Researchers first discovered a link between Trasylol and kidney failure in the early 1980s when lab animals that received ... Read More

Trasylol Pulled From Worldwide Market

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. The FDA cannot identify a patient population in which the use of Trasylol (aprotinin) outweighs the risk, Dr. John K. Jenkins, director of the FDA’s Office of New Drugs, said at an early morning news conference Monday. However, he added, “The suspension will include a slow phase-out of Trasylol from the marketplace, to decrease the possibility of shortages of the ... Read More

One in fifty Trasylol patients dies

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. Known as BART, the study randomly administered one of three drugs to the patients: Trasylol, Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid). BART sought to answer questions about Trasylol’s safety and efficacy, despite the fact that the drug has been in use for over twenty years. Was Trasylol more effective than alternative drugs in controlling bleeding during cardiac surgery? And, how did rates ... Read More

FDA announces withdrawal of remaining Trasylol

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. Beginning immediately, Trasylol will belong to a class of drugs that require a special protocol for use. Patients who are at a high risk for blood loss during coronary artery bypass graft surgery may receive ... Read More

Trasylol: just one of Bayer’s woes

An article in this week’s Business Week reveals a dualistic Bayer. On one hand, the pharmaceutical giant is “flush with success,” with projected sales just shy of $50 billion and increased dividends for shareholders. On the other hand, Bayer has been racked by a sequence of bad luck that threatens to sully its future fiscal health and innovation. What are the elements at work behind this dichotomy? Trasylol, Bayer’s injectable aprotinin for heart patients, is largely responsible for the gloom that many analysts forecast for Bayer. Approved by the FDA in 1993 for use in controlling blood loss during heart ... Read More

Death by Trasylol: one man’s story

Joseph Randone was a healthy 52-year old family man from Long Island when he underwent heart valve replacement surgery at Stony Brook University Hopsital in New York. The risks were low, according to his surgeon. Joe would likely return home to recover after less than a week in the hospital. Months later, Randone was still in the hospital fighting a losing battle for his life. The problem began during surgery, when Randone was hooked to an IV drip containing Trasylol for four hours. Trasylol is administered to control blood loss during heart surgery. It is one of the most widely ... Read More