Trasylol Recall: Risk of Kidney Failure and Death for Heart Surgery Injection

After initially issuing a temporary withdrawal of their heart surgery drug in November, Bayer AG has now indicated that they will be removing the remaining supply of Trasylol from all U.S. markets. The announcement comes after the release of a study Wednesday by the New England Journal of Medicine which found that the use of Trasylol (aprotonin) increased the risk of death by 54% when compared with cheaper alternative drugs.

The study was stopped in October 2007, after preliminary results found a higher death rate among users of Trasylol. Approximately 2,300 individuals who were at a high risk for bleeding during heart surgery, or those with multiple health problems, were randomly assigned to groups which received Trasylol, or one of two alternative drugs to control bleeding. According to the final analysis, six percent of those treated with Trasylol died within 30 days of surgery, compared with four percent for those treated with other drugs.

At the request of the FDA, Bayer agreed to temporarily withdraw Trasylol in November 2007 once the preliminary data from the study was reviewed. However, now that the full analysis has been released, a Trasylol recall has been issued to remove any remaining supplies of the heart surgery injection.

Did You Know? Millions of Philips CPAP Machines Recalled

Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.

Learn More

Limited access to Trasylol will still remain possible under a very strict protocal which only allows the drug to be used where doctors can verify that the benefits of the drug clearly outweigh the risks. The protocol only allows doctors to use it where one of the alternative medications can not be used and the patient is at an increased risk of blood loss and transfusions during bypass surgery.

Bayer faces at least 78 Trasylol lawsuits filed by heart surgery patients who were given the aprotinin injection to control bleeding and subsequently suffered kidney failure, a heart attack, stroke or death.

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Have Your Comments Reviewed by a Lawyer

Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Direct Filing of NEC Lawsuits Against Similac, Enfamil Manufacturers To Be Permitted in MDL
Direct Filing of NEC Lawsuits Against Similac, Enfamil Manufacturers To Be Permitted in MDL (Posted 4 days ago)

A federal judge plans to approve direct filing of future NEC lawsuits straight to the MDL court, streamlining the process for parents pursuing claims against the makers of Similac and Enfamil cow's milk-based formula.