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| |  FDA Issues Warning On Abbokinase Use ROCKVILLE, MD -- Jan. 26, 1999 -- The United States Food and Drug Administration is recommending that the use of Abbott Laboratories’ Abbokinase (urokinase) be reserved for only those situations where 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. The letter, which was dated Jan. 25, 1999, appeared on the FDA’s Center for Biologics Evaluation and Research website. The letter states that during recent inspections of Abbott Laboratories and its supplier of the human neonatal kidney cells used in the manufacture of Abbokinase, the FDA identified numerous significant deviations from the Current Good Manufacturing Practice regulations designed to help assure product safety. Abbokinase is produced from primary cultures of kidney cells harvested post-mortem from human neonates. Products manufactured from human source materials have the potential to transmit infectious agents. While some procedures to help control such risks in products of human source are in place, recent manufacturing inspections revealed deficiencies in some of the procedures used by Abbott and its supplier of the human neonatal kidney cells that could increase the risk of transmitting infectious agents, they write. In considering this risk, the FDA said the prescriber should be aware of the following information regarding currently available lots of Abbokinase: -- The kidney cells used in the manufacture of this product were harvested post-mortem from human neonates from a population at high risk for a variety of infectious diseases, including tropical diseases. The screening of potential donors did not include the questioning of the mothers to determine infectious disease status or specific risk factors for infectious diseases. Although some efforts were made by Abbott’s supplier to screen and test the mothers, neonate donors and kidney cells, Abbott’s testing of the materials it received indicates that these measures were not consistently or reliably performed. -- Neither the mothers nor the neonate donors were tested for hepatitis C virus (HCV) infection. Abbott has recently instituted a test for HCV in the kidney cells used in the manufacture of Abbokinase and negative test results have been obtained for currently available lots. However, Abbott has not validated this test. -- Prior to use in the manufacture of Abbokinase, the human kidney cells were harvested, stored and handled in a manner which may have permitted contamination with infectious agents. -- A viral inactivation procedure that substantially inactivates HIV and HCV in other biological products was used in the production of the currently available lots of Abbokinase. This process has variable effects on other infectious agents and has not been fully validated for viral inactivation of Abbokinase. The FDA said it is not aware of any cases of infectious diseases that can be attributed to the use of Abbokinase. However, the likelihood that cases of infectious diseases caused by Abbokinase, if any, would have been recognised as such and reported to FDA is probably very low. Therefore, the actual risk to patients of developing an infectious disease as a result of using Abbokinase is unknown. FDA approved indications for Abbokinase are: pulmonary embolism, coronary artery thrombosis, and IV catheter clearance. It should also be noted that the FDA has not approved the use of Abbokinase for clearance of peripheral venous and arterial obstructions or for clearance of arterio-venous cannulae. Abbott has committed to updating the labelling for Abbokinase to include the information regarding the potential risk for transmission of infectious diseases and to expeditiously correcting the deviations from Current Good Manufacturing Practice.
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