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From the Food and Drug Administration
March 3, 1999

Warning on Abbokinase

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Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999American Medical Association

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JAMA. 1999;281(9):786. doi:10.1001/jama.281.9.786

The FDA has issued an important drug warning to health care providers regarding the potential risks of transmitting infectious agents (including hepatitis C virus and HIV) associated with the use of the thrombolytic urokinase marketed by Abbott Laboratories as Abbokinase. During recent inspections of Abbott and its supplier of the cells used in the manufacture of Abbokinase, FDA identified numerous significant deviations from the current good manufacturing practice (CGMP) regulations. Accordingly, FDA recommends that currently available Abbokinase be reserved for only those situations in which a physician has considered the alternatives and has determined that the use of Abbokinase is critical to the care of a specific patient in a specific situation.

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