title: [Surveillance of the safety of intravesical BCG therapy in France: quantitative analysis of serious adverse events notified over a period of five years].
abstract: Intravesical BCG therapy remains the first-line prophylactic treatment for recurrent superficial bladder tumours. However, the safety of this drug requires close and rigorous surveillance due to rare, but sometimes serious complications reported after treatment. A quantitative analysis of serious adverse events (SAE) notified in France since marketing of BCG for intravesical immunotherapy (Connaught strain) and over a five-year period (September 1996-September 2001) revealed the following results: During this period, 158 SAEs were spontaneously reported to the Aventis Pasteur Central Pharmacovigilance Department. Of these 158 SAEs, 17 were local, 20 were regional and 121 were systemic. 64% of the 121 systemic SAEs were attributed to suspected BCG infection, 24% consisted of immune disorders and 12% were of unknown origin. Estimation of the SAE notification rate over this 5-year period was 0.37 SAE per 100 treated 100 patients. A tendency towards a lower SAE notification rate has been observed over the last two years. This tendency is concomitant with an information campaign on this drug. A continuing effort by prescribers to report adverse events of BCG-IT and strict compliance with precautions should continue to improve the safety profile of this drug.
authors.affiliation: Aventis Pasteur, Département des Affaires Médicales Globales, 2, avenue Pont Pasteur, 69367 Lyon, France. henri.debois@fond-merieux.org
authors.forename: Henri
authors.initials: H
authors.lastname: Debois
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Loupi
authors.forename: Pierre
authors.initials: P
authors.lastname: Saliou
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000283:Administration, Intravesical; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects*; D005602:France; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods; D012449:Safety; D001749:Urinary Bladder Neoplasms / Q000628:therapy
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine