2002 Safety Alert - Abbokinase (urokinase)
October 10, 2002
Dear Healthcare Professional:
Abbott Laboratories received approval from the U.S. Food and Drug Administration (FDA) on October 10, 2002, to reintroduce Abbokinase® (urokinase) to the medical community.
During the product's absence from the market, Abbott continued to receive valuable insight from healthcare professionals like you regarding the changing nature of thrombolytic use. As a result of what we have learned from you, we have focused our efforts to return Abbokinase to the market solely for the treatment of pulmonary embolism. Toward this end, the labeling for this product has been revised. A summary of important changes made to select sections of the labeling is presented below:
Indications and Usage
Abbokinase is indicated for the lysis of massive pulmonary emboli and pulmonary emboli accompanied by unstable hemodynamics.
Information regarding post-marketing reports of anaphylaxis and other infusion reactions has been added, as well as class information regarding the potential for cholesterol embolization.
The safety information has been updated based on a thorough analysis of post-marketing safety data obtained over a 20-year period. Specifically, the revised adverse reaction information now incorporates safety information generated from both Abbott's clinical trials and post-marketing experience.
The complete newly approved package insert for Abbokinase is enclosed. If you require additional medical information, please contact Abbott Medical Communications at 1-800-615-0187.
The reintroduction of Abbokinase is a notable milestone that allows patients to benefit once again from this important therapy. Abbott is proud to have fulfilled our commitment to reintroduce Abbokinase - a product that has been used for more than 20 years to treat an estimated four million patients. We are confident that Abbokinase will again provide the reliability and safety needed in treating patients.
Healthcare professionals should report any serious adverse events possibly associated with the use of Abbokinase to Abbott Laboratories at 1-800-441-4100. Alternatively, this information may be reported to FDA's MedWatch reporting system by phone (1-800-FDA-1088), facsimile (1-800-FDA-1078), or the MedWatch website at www.fda.gov/medwatch or mailed to MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787.
Should you have any questions about the product or need information on how to order Abbokinase, as it is available for immediate distribution, please contact your local Abbokinase representative, local wholesaler, or call Abbott Customer Service at 1-800-ABBOTT3.
We look forward to continuing to work closely with you in the future.
Charles J. Fisher Jr., MD
Divisional Vice President
Global Pharmaceutical Development
See enclosed package insert for full prescribing information.
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