title: Complications of BCG vaccine SSI® recent story and risk management plan: the French experience.
abstract: BACKGROUND
  As of January 2006, the BCG vaccine SSI® became the only BCG vaccine available for tuberculosis vaccination in France. The use of this vaccine led to significant changes in vaccination technique which were accompanied by a rapid increase in the number of adverse reactions (ADRs) reported. A national pharmacovigilance follow-up began in February 2006, and a risk management plan (RMP) was put in place in April 2006, made of three phases (carried out in June 2006, July 2006 and September 2006) with risk minimisation measures. The goal of this study was to evaluate the impact of the RMP on the amount of ADRs reported.
  
  
  METHODS
  Based on data collected by the regional pharmacovigilance centres and the MSD laboratory, the cases of locoregional ADRs spontaneously reported were analysed retrospectively from January 2005 to February 2006, and then prospectively up to June 2008, the date at which the national follow-up ended. The locoregional ADRs were divided into three categories: abscesses, local reactions or lymphadenopathy of more than 1 cm and suppurative lymphadenopathy. A parallel was then drawn between these data and the different phases of the RMP.
  
  
  RESULTS
  During the entire follow-up period, we note 1050 locoregional ADRs, of which 764 were abscesses (73% of all cases), 266 were local reactions and 20 involved suppurative lymphadenopathy.Locoregional ADRs increased rapidly from January 2006 onward, reaching a peak in August 006 and then falling and stabilising from December 2007 onward.The RMP was implemented when there was an increase in the number of ADRs reported. The drop in the number of these effects began 3 months after the first phase and 2 months after the second phase of the RMP. The third phase was not accompanied by a variation in the number of ADRs reported.
  
  
  CONCLUSIONS
  The RMP appears to have positive effect on the evolution of the number of ADRs, their decrease occurring rapidly after the risk minimisation measures of the first two phases. Nonetheless, these data should be confirmed by other studies on the efficacy of RMPs.
authors.affiliation: Department of Dermatology, CHU de Saint Etienne (Saint Etienne University Hospital), Saint Etienne, France. christelle.chol@hotmail.fr
authors.forename: Christelle
authors.initials: C
authors.lastname: Chol
authors.forename: Claire
authors.initials: C
authors.lastname: Guy
authors.forename: Alexis
authors.initials: A
authors.lastname: Jacquet
authors.forename: Anne
authors.initials: A
authors.lastname: Castot-Villepelet
authors.forename: Carmen
authors.initials: C
authors.lastname: Kreft-Jais
authors.forename: Frédéric
authors.initials: F
authors.lastname: Cambazard
authors.forename: Marie-Noelle
authors.initials: MN
authors.lastname: Beyens
authors.forename: Geneviève
authors.initials: G
authors.lastname: Mounier
authors.forename: Fakhria
authors.initials: F
authors.lastname: Marsille
authors.forename: Patrick
authors.initials: P
authors.lastname: Mismetti
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D001500:BCG Vaccine / Q000009:adverse effects*; D005602:France; D006801:Humans; D060735:Pharmacovigilance; D012308:Risk Management
chemical_list: D001500:BCG Vaccine