title: Drugs and cancer: an analysis of the French Pharmacovigilance Database.
abstract: BACKGROUND
  Our knowledge on cancers related to drugs remains limited. Among the different pharmacoepidemiological approaches assessing this risk, analysis of reports to pharmacovigilance (PV) system is uncommon.
  
  
  OBJECTIVE
  To review cancers registered as adverse drug reactions (ADRs) in the French Pharmacovigilance Database (FPVDB).
  
  
  METHODS
  This study was based on spontaneous reports of ADRs submitted to the French PV system. All cases of cancers reported in the FPVDB between 1995 and 2006 were reviewed. Cases with transgenerational effects, cases from patients with an history of primary cancer and cancers associated with antineoplastic drugs were excluded. Drugs were classified according ATC classification. Results. Out of 207 000 notifications, 414 cases of cancer (998 citations of drugs) were identified. Report s increased from 19 cases in 1995 to 70 in 2006. Patients' age ranged from 2 to 95 years. Gender was equally distributed. Most frequently reported cancers were lymphomas (22.7%), b asal or squamous cell carcinomas (16.4%) and leukemias (13.8%). Immunosuppressants (37.6%) were ranked in the first position followed by corticosteroids (9.3%). Potential drug-cancer associations, previously described in the literature (immunosuppressants, hydroxycarbamide, mitoxantrone, cyproterone and hormone replacement therapy) were found in the database. Other potential drug-cancer associations (leukemia and non-Hodgkin's lymphoma after exposition to nucleoside reverse-transcriptase inhibitors or interferon) were also identified.
  
  
  CONCLUSIONS
  Cancer notifications in a PV database, although usually considered as poorly generalizable to the general population, appears to be useful in the surveillance of cancer risk associated to drugs. It allows both confirmation of already known data and detection of new signals. Combination of present data with pharmacoepidemiological studies and collaborations with cancer registries would allow better identification of these risk signals.
authors.affiliation: Hôpitaux Universitaires de Toulouse, France. genevieve.durrieu@univ-tlse3.fr
authors.forename: Geneviève
authors.initials: G
authors.lastname: Durrieu
authors.forename: Benjamin
authors.initials: B
authors.lastname: Mazau
authors.forename: Jérémi
authors.initials: J
authors.lastname: Jégu
authors.forename: Maryse
authors.initials: M
authors.lastname: Lapeyre-Mestre
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Delord
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Montastruc
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000009:adverse effects; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D005260:Female; D005602:France / Q000453:epidemiology; D017325:Hepatitis B Vaccines / Q000009:adverse effects; D006728:Hormones / Q000009:adverse effects; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects; D006918:Hydroxyurea / Q000009:adverse effects; D007166:Immunosuppressive Agents / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000009:adverse effects; D009369:Neoplasms / Q000139:chemically induced* / Q000453:epidemiology; D060735:Pharmacovigilance; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D019380:Anti-HIV Agents; D018501:Antirheumatic Agents; D017325:Hepatitis B Vaccines; D006728:Hormones; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007166:Immunosuppressive Agents; D008942:Mitoxantrone; D006918:Hydroxyurea