The Case of Abbokinase and the FDA: The Events Leading to the Suspension of Abbokinase Supplies in the United States

Abstract

A shortage of urokinase (UK) developed in the United States in early 1999 as a result of an intervention by the Food and Drug Administration (FDA). This resulted from the findings of a routine inspection of Abbott Laboratories, the only source of recombinant UK (Abbokinase; Abbott Laboratories, Abbott Park, IL) in the U.S., and BioWhittaker (Walkersville, MD), the only source of the human neonatal kidney (HNK) cells, used by Abbott in the manufacture of Abbokinase. The FDA distributed an “Important Drug Warning Letter” on January 25, 1999, alerting physicians to a number of problems related to the manufacture of Abbokinase ( 1 FDA Important Drug Warning Letter, 1/25/99. Food and Drug Administration, Rockville, MD1999www.fda.gov/cber/ltr/abb012599.htm Google Scholar ). Subsequently, shipment of Abbokinase was stopped by Abbott. It recommenced briefly after several weeks and finally ceased in March 1999.