Bayer's Trasylol problems are growing following increasing reports of the drug's side effects. Trasylol has recently been linked to a higher risk of kidney damage, heart attack, and death in the five years following a patient undergoing bypass heart surgery. In 1993 Trasylol (Aprotinin) was approved by the Federal Drug Administration. Aprotinin is manufactured by Bayer under the brand name Trasylol. Over the past several years Trasylol sales continued to increase even though studies indicated serious Trasylol kidney damage side effects.
Most heart surgery patients don't know if they were given Trasylol during their open heart surgery. Many patients suffering from Trasylol kidney damage side effects don't know if they were given Trasylol during their surgery because the surgeon made the decision whether to administer the drug to stop excessive bleeding during surgery.
Trasylol affects the way in which blood clots. It is given to open heart surgery patients to prevent excessive bleeding side effects. Trasylol is mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. The drug has been in use for 13 years and a million patients have received it. One of the most serious complications for bypass surgery patients is excessive bleeding. Clotting medications such as Trasylol reduce the amount of blood transfusion needed during surgery. In 2006 The New England Journal of Medicine (NEJM) published a study that reported Trasylol problems with an increased risk of developing heart failure, kidney damage, myocardial infarction, and stroke in bypass heart surgery patients.
On September 21, 2006 the FDA's Cardiovascular and Renal Drug Advisory Committee met to evaluate current data regarding Trasylol side effects. On September 29, 2006, the FDA issued a public health advisory stating that it had new information that Bayer failed to disclose an earlier study that it had conducted involving 67,000 heart surgery patients. Preliminary review of this study suggested that Trasylol side effects included higher risks for stroke, congestive heart failure, kidney damage, and death. Bayer failed to disclose this study during the Advisory Committee on September 21, 2006.
Dr. Dennis Mangano, the lead author of the NEJM Trasylol side effects study, has noted that Trasylol problems occurred more frequently than those linked with the drug Vioxx. Dr. Mangano relates, "In fact our findings raise even more troubling concerns, for:
(1) aprotinin has been on the market for three times as long as Vioxx, yet few comprehensive safety studies have been conducted since approval;
(2) the life-threatening complications with aprotinin found here occurred far more frequently than those with Vioxx; and
(3) far less expensive generic alternatives to aprotinin which are equally effective in limiting bleeding have been available, but have been underused."
The observational study concluded, "Our findings raise serious concerns regarding the safety of an approved drug intended to limit blood loss in at-risk patients undergoing surgery." Mangano related his opinion regarding the ongoing use of Trasylol, stating "In good conscience, I could not administer (Trasylol) to this group of patients, especially given the availability of safer alternatives." Trasylol problems continue to be studied and the FDA is monitoring Trasylol kidney damage side effects and advising physicians to consider limiting the drug's use.
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