title: Tedizolid phosphate for the management of acute bacterial skin and skin structure infections: safety summary.
abstract: The novel oxazolidinone tedizolid phosphate is in late-stage clinical development. In an effort to improve efficacy and safety, the adverse event profile and safety aspects of tedizolid phosphate have been evaluated in several preclinical animal models and through ongoing clinical trials. Early dose-ranging studies demonstrated a favorable overall adverse event profile and low thrombocytopenia rates, which have been consistently confirmed in phase 2 and 3 clinical trials. Pharmacokinetic modeling suggests a lower potential for monoamine oxidase interaction, and animal and human subject testing has confirmed these predictions. Studies in special patient populations showed a consistent and predictable pharmacokinetic profile across age groups and comorbid conditions, without evidence of increased incidence of adverse effects over matched controls. The favorable safety profile makes tedizolid phosphate an important new option for the management of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus.
authors.affiliation: Cellular and Molecular Pharmacology.
authors.forename: Debaditya
authors.initials: D
authors.lastname: Das
authors.forename: Paul M
authors.initials: PM
authors.lastname: Tulkens
authors.forename: Purvi
authors.initials: P
authors.lastname: Mehra
authors.forename: Edward
authors.initials: E
authors.lastname: Fang
authors.forename: Philippe
authors.initials: P
authors.lastname: Prokocimer
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D004195:Disease Models, Animal; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D010755:Organophosphates / Q000009:adverse effects* / Q000627:therapeutic use; D010080:Oxazoles / Q000009:adverse effects* / Q000627:therapeutic use; D013207:Staphylococcal Skin Infections / Q000188:drug therapy*
chemical_list: D000900:Anti-Bacterial Agents; D010755:Organophosphates; D010080:Oxazoles; C515040:tedizolid phosphate
keywords: ABSSSI; clinical trials; safety; tedizolid phosphate; treatment-emergent adverse events