FDA Doesn't Receive Additional Safety Study From Bayer About Heart Surgery Medication Trasylol Until After September 2006 Hearings Concluded

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Bayer did not present a critical medical study to the FDA when public hearings were held in September 2006, to review the safety of Bayer's open heart surgery medication Trasylol.

Rosenbaum Faria, LLP, in their continuing monitoring of Bayer’s Trasylol, has discovered the FDA was not presented with an important medical study during public hearings held in September 2006 to determine the safety of the heart surgery medication.

Bayer AG, the German pharmaceutical giant, presented the 67,000 patient study to the FDA after the public hearings were closed. The study indicates an increased risk of renal failure, heart attack, and stroke for those patients receiving the injection Trasylol (aprotinin) during cardiac bypass surgery.

The FDA has been reassessing the safety of Trasylol since February, when articles in the New England Journal of Medicine (N Engl J Med. 2006; 354:353-365, Jan 21, 2006) and other publications indicated Trasylol caused an increase in renal failure, myocardial infarction, stroke, and encephalopathy. More than 600,000 patients worldwide were treated with Trasylol in 2005, bringing in an estimated $291 million for Bayer. The article concluded, “In contrast, the less expensive generic medications aminocaproic acid and tranexamic acid are safe alternatives.”

“Although Bayer has suspended two employees for choosing to withhold the report ( http://301url.com/suspended), it doesn’t change the fact that the report was available but was not provided to the FDA for use during the public hearings,” said Cory Rosenbaum, partner in Manhattan-based law firm, Rosenbaum Faria, LLP.

The FDA’s website indicates their intention to continue to evaluate the drug and the new data contained in the report, but it has already advised doctors who use Trasylol to carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain. The FDA has further warned physicians to consider limiting their use of Trasylol to situations where clinical benefits outweigh the potential risks.

“Our research is showing that patients would have been safer being given an $11 medicine instead of Bayer’s $1,300 injection. We are going to keep a watchful eye on the FDA in this matter, and continue to report developments to our clients and the general public through our website,” said Mr. Rosenbaum. “With a drug like this out there since 1994, we’re just hoping this won’t turn into another Vioxx.”

Vioxx Cases: MDL 1657, US District Court for the Eastern District of Louisiana

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Cherie Yannone