title: Predictability of serious adverse reaction alerts for monoclonal antibodies.
abstract: OBJECTIVE
  We analyzed the predictability of the United States Food and Drug Administration's Medwatch safety alerts on monoclonal antibodies with the aim of assessing the adequacy of their pre-approval safety evaluation.
  
  
  METHODS
  An alert was considered observed when increased frequency, severity, or other new properties were reported for previously identified suspected adverse reactions.
  
  
  RESULTS
  Up until January 2010, 36 safety alerts to mAbs were issued containing 61 alert terms. Just above a half (32) of the alert terms were assessed as observed.
  
  
  CONCLUSIONS
  In addition to the observed reactions, a large proportion of unobserved reactions could have been predicted based on the mechanism of action and antibody target. Although retrospective assessment necessarily implies an element of subjectivity, there appears to be room for improvement in predicting adverse reactions to mAbs.
  
  
  CONCLUSIONS
  Adverse reaction risk management and pharmaceutical care must focus on the observed reactions, but all effort should be made to extrapolate from the observed reactions to predict further safety issues. This should be taken into account by marketing authorization holders, prescribers, clinical trial sponsors, investigators and regulators.
authors.affiliation: School of PhD Studies, University Pharmacy, Department of Pharmacy Administration, Semmelweis University, Budapest, Hungary. v.stanulovic@accelsiors.com
authors.forename: V
authors.initials: V
authors.lastname: Stanulovic
authors.forename: R
authors.initials: R
authors.lastname: Zelko
authors.forename: S
authors.initials: S
authors.lastname: Kerpel-Fronius
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D006801:Humans; D012308:Risk Management / Q000379:methods*; D012720:Severity of Illness Index; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal