title: Long-term safety experience with bendamustine for injection in a real-world setting.
abstract: BACKGROUND
  Bendamustine hydrochloride (bendamustine) was approved for first-line treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent B-cell non-Hodgkin's lymphoma (NHL). Pharmacovigilance data have been collected since bendamustine's approval to enhance understanding of its long-term safety profile. Here we provide an overview of the pharmacovigilance data for bendamustine that have led to label updates related to safety and administration since its approval.
  
  
  METHODS
  Adverse events (AEs) captured from 12 quarterly postmarketing periodic adverse drug experience reports spanning 2008-2015 were included and summarized. AEs were classified as serious or nonserious and expected or unexpected.
  
  
  RESULTS
  Adverse events that resulted in label updates included Stevens-Johnson syndrome, toxic epidermal necrolysis, extravasation, secondary neoplasm, and drug reactions with eosinophilia and systemic symptoms. Preventive measures for tumor lysis syndrome were revised. Although this review may be limited by voluntary reporting, the adverse events reported for bendamustine in a large, heterogeneous population with a long follow-up relative to recently approved treatments provide a much broader understanding of its safety profile.
  
  
  CONCLUSIONS
  Based on these observational data, bendamustine appears to have a favorable risk-benefit profile and remains a useful option when considering a management strategy in patients with CLL and NHL.
authors.affiliation: a Division of Hematology/Oncology , New York-Presbyterian/Weill Cornell Medicine , New York , NY , USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Martin
authors.affiliation: b James P. Wilmot Cancer Center , University of Rochester Medical Center , Rochester , NY , USA.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Barr
authors.affiliation: c North American Drug Safety and Pharmacovigilance , Teva Pharmaceuticals , Frazer , PA , USA.
authors.forename: Leonard
authors.initials: L
authors.lastname: James
authors.affiliation: d North American Affairs - Oncology , Teva Pharmaceuticals , Frazer , PA , USA.
authors.forename: Ashutosh
authors.initials: A
authors.lastname: Pathak
authors.affiliation: e Division of Medical Oncology , Washington University School of Medicine , St. Louis , MO , USA.
authors.forename: Brad
authors.initials: B
authors.lastname: Kahl
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000009:adverse effects; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing
chemical_list: D018906:Antineoplastic Agents, Alkylating; D000069461:Bendamustine Hydrochloride
keywords: Bendamustine; pharmacovigilance; postmarketing; surveillance