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Aprotinin (marketed as Trasylol) Patient Information Sheet

Patient Information Sheet
Aprotinin (marketed as Trasylol)

This information in the FDA Alerts is not current. The FDA has issued new information about this safety issue, please see http://www.fda.gov/cder/drug/infopage/aprotinin/default.htm

FDA ALERT [9/2006]

We have received results from another study of the possible harms from treatment with Trasylol. We are evaluating this study and will update this Alert when we are finished with the evaluation.

FDA ALERT [2/2006]    A new study suggests that Trasylol may increase the chance for serious side effects such as kidney failure, heart attack, and stroke in some patients. 

Another new study suggests that Trasylol may increase the chance for kidney failure.

These side effects have not been seen in other studies with Trasylol.

The FDA is looking at the results from these two new studies and will provide more information as it becomes known.

This information reflects FDA’s preliminary analysis of data concerning this drug.  FDA is considering, but has not reached a final conclusion about, this information.  FDA intends to update this sheet when additional information or analyses become available.

This is a summary of the most important information about Trasylol.  For details, talk to your healthcare professional.

What Is Trasylol?

Trasylol is a medicine given before heart surgery to reduce bleeding and the need for blood transfusions.  Trasylol is made from tissue taken from cows.

What Are The Risks?

The following are the major potential risks and side effects of Trasylol therapy. However, this list is not complete.

Serious Allergic Reaction (Anaphylactic Reaction) This is a rare but serious allergic reaction that happens suddenly and can be life threatening or cause death.  Patients who have had Trasylol in the past have a higher chance for anaphylactic reactions with a new dose of Trasylol.

What Should I Tell My Healthcare Professional?

If you are scheduled to have heart surgery, ask your doctor if he or she intends to use Trasylol.  Tell your healthcare professional if you:

  • Have had Trasylol in the past

  • Have had heart surgery

  • Are allergic to any medicines

  • Have kidney disease

  • Are pregnant, trying to become pregnant, or are breast-feeding

  • Are taking other medicines.  Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570
Druginfo@fda.hhs.gov

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