title: [Adverse effects of the vaccines Tétracoq, IPAD/DTCP and DTCP. A French study of regional drug monitoring centers].
abstract: On request of the French Drug Agency, the Regional Pharmacovigilance Center (RPVC) of Tours has been in charge of the analysis of adverse events (AEs) associated with tetravalent vaccines IPAD/DTCP, DTCP and Tétracoq, and reported to the RPVC or to the pharmaceutical companies that produce them.
  
  
  METHODS
  All AEs spontaneously reported during use of one of these vaccines to one of the French Pharmacovigilance Centers or to the responsible firms between January 1, 1986 and December 31, 1990 were take into account. An AE was noted as "serious" in accordance with the European criteria. The incidence of adverse effects was estimated by evaluating the ratio of adverse effects and the number of sales of the vaccine for the same period.
  
  
  RESULTS
  From 1986 to 1990, 631 AEs (with 19 duplicate cases) associated with tetravalent vaccines in 606 children (75% < 1 year) were reported. The most frequent AEs were: local AEs at the site of injection (43%), neurologic disorders (12%), hyperthermia (10%) and allergic reactions (10%). Serious AEs represented 25% of all AEs and were similar to those usually described with these vaccines, particularly persistent crying (23), febrile seizures (12), apyretic seizures (14), uneasiness (28) and, rarely, shock (3).
  
  
  CONCLUSIONS
  Incidences of AEs reported with pentavalent vaccines are very low, probably underestimated because of the under-notification by prescribers of AEs of vaccines licensed some time ago. It will be interesting to compare these data with AEs of penta- and hexavalent vaccines since they have replaced tetravalent vaccines.
authors.affiliation: Service de pharmacologie clinique, Hôpital Bretonneau, Tours, France.
authors.forename: A P
authors.initials: AP
authors.lastname: Jonville-Béra
authors.forename: E
authors.initials: E
authors.lastname: Autret-Leca
authors.forename: M
authors.initials: M
authors.lastname: Radal
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D001927:Brain Diseases / Q000209:etiology; D002648:Child; D002675:Child, Preschool; D003448:Crying / Q000502:physiology; D004168:Diphtheria Toxoid / Q000009:adverse effects*; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D004345:Drug Industry; D005260:Female; D005334:Fever / Q000209:etiology; D005602:France; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D015994:Incidence; D007223:Infant; D007273:Injections, Intramuscular / Q000009:adverse effects; D008297:Male; D010567:Pertussis Vaccine / Q000009:adverse effects*; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects*; D011595:Psychomotor Agitation / Q000209:etiology; D012640:Seizures / Q000209:etiology; D012769:Shock / Q000209:etiology; D012871:Skin Diseases / Q000209:etiology; D013745:Tetanus Toxoid / Q000009:adverse effects*; D017778:Vaccines, Combined / Q000009:adverse effects*
chemical_list: C051021:DTPP vaccine; D004168:Diphtheria Toxoid; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D010567:Pertussis Vaccine; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D017778:Vaccines, Combined
vernacular_title: Effets indésirables des vaccins Tétracoq, IPAD/DTCP et DTCP. Enquête française des centres régionaux de pharmacovigilance.