Traysol Heart Surgery Drug: FDA Announces Suspension of Marketing Until Review Completed
Bayer Schering Pharma, the manufacturer of popular heart surgery drug Trasylol, will suspend all marketing of the drug until a review can be conducted of recent Canadian research which has implicated the drug in a higher risk of death for cardiac patients.
Trasylol is designed to help blood clot during surgery, reducing the need for patients to receive blood transfusions during heart operations. The U.S. Food and Drug Administration (FDA) has previously associated the drug with side effects such as kidney failure, congestive heart failure and strokes, but has repeatedly declined to take action to remove the drug from the market, noting that there are few alternatives to the drug for patients at risk of excessive bleeding during heart surgery.
Last fall, Trasylol and Bayer made headlines when an article in the New England Journal of Medicine exposed a cover-up of manufacturer-sponsored research which implied that the drug could injure or kill patients. This most recent study involving Trasylol was halted to protect the safety of the drug trial participants when it became apparent that the drug was increasing the risk of death for cardiac patients.
Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:
- An FDA announcement that some heart imaging drugs cause injuries and fatalities
- An FDA warning regarding the safety of "stay awake" drug, Provigil
- A new study linking preeclampsia to heart disease risk
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