title: Estimate of venous thromboembolism and related-deaths attributable to the use of combined oral contraceptives in France.
abstract: OBJECTIVE
  To estimate the number of venous thromboembolic events and related-premature mortality (including immediate in-hospital lethality) attributable to the use of combined oral contraceptives in women aged 15 to 49 years-old between 2000 and 2011 in France.
  
  
  METHODS
  French data on sales of combined oral contraceptives and on contraception behaviours from two national surveys conducted in 2000 and 2010 were combined to estimate the number of exposed women according to contraceptives generation and age. Absolute risk of first time venous thromboembolism in non-users of hormonal contraception and increased risk of thromboembolism in users vs. non-users of hormonal contraception were estimated on the basis of literature data. Finally, immediate in-hospital lethality due to pulmonary embolism and premature mortality due to recurrent venous thromboembolism were estimated from the French national database of hospitalisation and literature data.
  
  
  RESULTS
  In France, more than four million women are daily exposed to combined oral contraceptives. The mean annual number of venous thromboembolic events attributable to their use was 2,529 (778 associated to the use of first- and second-generation contraceptives and 1,751 to the use of third- and fourth-generation contraceptives), corresponding to 20 premature deaths (six with first- and second-generation contraceptives and fourteen with third- and fourth-generation contraceptives), of which there were eight to nine immediate in-hospital deaths. As compared to the use of first- and second-generation contraceptives, exposure to third- and fourth-generation contraceptives led to a mean annual excess of 1,167 venous thromboembolic events and nine premature deaths (including three immediate in-hospital deaths).
  
  
  CONCLUSIONS
  Corrective actions should be considered to limit exposure to third- and fourth-generation contraceptives, and thus optimise the benefit-risk ratio of combined oral contraception.
authors.affiliation: Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France.
authors.forename: Aurore
authors.initials: A
authors.lastname: Tricotel
authors.affiliation: Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France.
authors.forename: Fanny
authors.initials: F
authors.lastname: Raguideau
authors.affiliation: Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France.
authors.forename: Cédric
authors.initials: C
authors.lastname: Collin
authors.affiliation: Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France.
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Zureik
mesh_terms: D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects*; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D054556:Venous Thromboembolism / Q000209:etiology* / Q000401:mortality*; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined
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