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U.S. Department of Health and Human Services

Safety

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Abbokinase (urokinase)

Audience: Cardiologists, Intensivists, and other healthcare professionals

FDA and Abbott announced the reintroduction of Abbokinase (urokinase) for use in the lysis of massive pulmonary emboli and pulmonary emboli accompanied by unstable hemodynamics. The WARNINGS section of the labeling has been strengthened to include post-marketing reports of anaphylaxis, other infusion reactions, and class information regarding the potential for cholesterol embolization. The ADVERSE REACTIONS section of the product labeling reflects the analysis of post-marketing safety data.

[October 10, 2002 - Letter - Abbott Laboratories]