title: [Evaluation of tolerance to endovesical BCG treatment in France: analysis of severe adverse effects notified in 3 years].
abstract: OBJECTIVE
  Intravesical BCG therapy remains the first-line prophylactic treatment for recurrences of superficial bladder tumours. However, necessary the safety of this medicinal product, for which a potential risk of complications was demonstrated during development, needs to be evaluated.
  
  
  METHODS
  Based on spontaneous notifications of adverse events reported according to good pharmacovigilance practice and in the context of a survey conducted jointly with Health Authorities, the authors present an analysis of adverse event notifications received by the manufacturer over a three-year period. A summary of serious adverse events (SAE) was established and hypotheses concerning factors predisposing to these adverse events were discussed. Finally, practice guidelines were formulated.
  
  
  RESULTS
  During this period, 97 SAEs were reported spontaneously, including 12 local SAEs, 12 regional SAEs and 73 systemic SAEs. 46 of the 73 systemic SAEs were suspected to be due to BCG infection, 18 were related to immune disorders and the cause of 9 SAEs could not be determined. Several hypotheses are formulated concerning the circumstances leading to the onset of these SAEs and practice guidelines are proposed.
  
  
  CONCLUSIONS
  Pharmacovigilance has allowed a better understanding of the qualitative and quantitative safety of BCG-IT in France. Hypotheses concerning factors predisposing to adverse effects were formulated and practice guidelines were proposed. It is essential to continue this collaboration between practitioners, Health Authorities and the manufacturer to ensure optimal use of this medicinal product.
authors.affiliation: Aventis Pasteur, Département Affaires Médicales, 2, avenue Pont Pasteur, 69367 Lyon.
authors.forename: H
authors.initials: H
authors.lastname: Debois
authors.forename: E
authors.initials: E
authors.lastname: Loupi
authors.forename: P
authors.initials: P
authors.lastname: Saliou
authors.forename: H
authors.initials: H
authors.lastname: Blangy
authors.forename: D
authors.initials: D
authors.lastname: Loeuille
authors.forename: P
authors.initials: P
authors.lastname: Gillet
mesh_terms: D000276:Adjuvants, Immunologic; D000283:Administration, Intravesical; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects*; D005602:France; D006801:Humans; D013997:Time Factors
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine
vernacular_title: Evaluation de la tolérance de la BCG thérapie endovésicale en France: analyse des évènements indésirables graves notifiés sur une période de trois ans.