title: Recurrent life-threatening deep tissue hematomas after switching to generic enoxaparin: a report and perspective on the approval process for biological compounds.
abstract: In the United States, the Food and Drug Administration (FDA) has allowed makers of biologic therapies to use the abbreviated new drug application, which does not require safety and efficacy studies. Instead this relies on proving equivalency with the original compound and demonstrating in vitro activity and similar pharmacodynamics. In the United States, a low-molecular-weight heparin, enoxaparin, was recently approved in a generic format through the abbreviated new drug application. We present a patient treated with branded enoxaparin for 4 years with no complications. After the switch to the generic enoxaparin, the patient developed 2 life-threatening hemorrhages within 4 months of the initiation of the compound. This case suggests that the FDA should follow the European Medicine Administration (EMA) guidance by tightening its approval process for generic bioequivalents and requiring studies demonstrating similar safety and efficacy as the parent compound, prior to approval of a generic biologically active compound.
authors.affiliation: The Ohio State University College of Medicine, Columbus, OH, USA. benjamin.kaffenberger@osumc.edu
authors.forename: Benjamin H
authors.initials: BH
authors.lastname: Kaffenberger
authors.forename: Tanios
authors.initials: T
authors.lastname: Bekaii-Saab
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects*; D017277:Drug Approval; D016568:Drugs, Generic / Q000008:administration & dosage / Q000009:adverse effects*; D017984:Enoxaparin / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006406:Hematoma / Q000139:chemically induced*; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D008875:Middle Aged; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000925:Anticoagulants; D016568:Drugs, Generic; D017984:Enoxaparin