ABSTRACT
With its approval by the European Medical Evaluation Agency (EMEA) in 1997 and by the U.S. Food and Drug Administration (FDA) in 1998 for the treatment of heparin-induced thrombocytopenia (HIT) complicated by thrombosis, lepirudin (Refludan, Schering AG, Berlin; licensed to Berlex Laboratories, Montville, NJ [US, Canada], and to Pharmion, Cambridge, UK [all other countries]) became the first direct thrombin inhibitor (DTI) available for this indication. The scientific literature has documented experience with lepirudin in more than 8500 patients. The total number of patients exposed to this anticoagulant (until 2003) is estimated at between 35,000 and 60,000 worldwide.
