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Urokinase product reenters the market
From Nursing, 1/1/03

ABBOKINASE

The FDA has approved the reintroduction of Abbokinase, Abbott's brand of urokinase. The medication is approved for the lysis of massive pulmonary emboli and pulmonary emboli accompanied by unstable hemodynamics.

The drug was first approved in 1978, but production was suspended in 1999 due to lack of compliance with the FDA's good manufacturing practice requirements. Abbott is now in compliance with FDA requirements.

The drugs warning labeling has been changed to include reports of allergic-type reactions and rare cases of anaphylaxis, infusion reactions (generally characterized by fever, chills, and rigors), and the potential for cholesterol embolization. Safety information has been updated based on an analysis of postmarketing safety data obtained over a 20-year period.

The most serious adverse reaction associated with Abbokinase is bleeding. It's contraindicated for people at risk for bleeding, those with uncontrolled hypertension, and those with a history of allergic type-III reaction to urokinase.

Copyright Springhouse Corporation Jan 2003
Provided by ProQuest Information and Learning Company. All rights Reserved

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