Estimate of venous thromboembolism and related-deaths attributable to the use of combined oral contraceptives in France

PLoS ONE

Volumn 9, Issue 4, 2014, Pages

  Tricotel, Aurore ^a   Raguideau, Fanny ^a   Collin, Cédric ^a   Zureik, Mahmoud ^a  

^a French National Agency for Medicines and Health Products Safety   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CHLORMADINONE; DESOGESTREL; DIENOGEST; DROSPIRENONE; GESTODENE; LEVONORGESTREL; NOMEGESTROL; NORETHISTERONE; NORGESTIMATE; NORGESTREL; ORAL CONTRACEPTIVE AGENT;

ADOLESCENT; ADULT; ARTICLE; CONTRACEPTIVE BEHAVIOR; DRUG FATALITY; FEMALE; FRANCE; HORMONAL CONTRACEPTION; HUMAN; LUNG EMBOLISM; PHARMACOEPIDEMIOLOGY; PREMATURE MORTALITY; VENOUS THROMBOEMBOLISM; EPIDEMIOLOGY; INCIDENCE; MIDDLE AGED; MORTALITY; YOUNG ADULT;

ADOLESCENT; ADULT; CONTRACEPTIVES, ORAL, COMBINED; FEMALE; FRANCE; HUMANS; INCIDENCE; MIDDLE AGED; VENOUS THROMBOEMBOLISM; YOUNG ADULT;

EID: 84899894653     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0093792     Document Type: Article

References (33)

1. Jordan WM, Anand JK (1961) Pulmonary embolism. The Lancet 278: 1146-1147. doi:10.1016/S0140-6736(61)91061-3.
2. Boyce J, Fawcett JW, Noall EW (1963) Coronary thrombosis and Conovide. Lancet 1: 111.
3. Baillargeon J-P, McClish DK, Essah PA, Nestler JE (2005) Association between the current use of low-dose oral contraceptives and cardiovascular arterial disease: a meta-analysis. J Clin Endocrinol Metab 90: 3863-3870. doi:10.1210/jc.2004-1958. (Pubitemid 41058144)
4. Lidegaard Ø, Løkkegaard E, Jensen A, Skovlund CW, Keiding N (2012) Thrombotic stroke and myocardial infarction with hormonal contraception. N Engl J Med 366: 2257-2266. doi:10.1056/NEJMoa1111840.
5. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception (1995) Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. Lancet 346: 1582-1588.
6. Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C (1995) Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet 346: 1589-1593. (Pubitemid 26001840)
7. Bloemenkamp KW, Rosendaal FR, Helmerhorst FM, Büller HR, Vandenbroucke JP (1995) Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a thirdgeneration progestagen. Lancet 346: 1593-1596. (Pubitemid 26001841)
8. Spitzer WO, Lewis MA, Heinemann LA, Thorogood M, MacRae KD (1996) Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women. BMJ 312: 83-88.
9. Lidegaard Ø, Løkkegaard E, Svendsen AL, Agger C (2009) Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 339: b2890.
10. Lidegaard Ø, Nielsen LH, Skovlund CW, Skjeldestad FE, Løkkegaard E (2011) Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9. BMJ 343: d6423.
11. Parkin L, Sharples K, Hernandez RK, Jick SS (2011) Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. BMJ 342: d2139.
12. Jick SS, Hernandez RK (2011) Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ 342: d2151.
13. Public Health Code - Article L5121-17 (n.d.). Légifrance website. Available: http://www.legifrance.gouv.fr/affichCodeArticle.do?idArticle= LEGIARTI000025124663&cidTexte=LEGITEXT000006072665&dateTexte= 20140314&oldAction=rechCodeArticle. Accessed 2014 Mar 14.
14. ANSM website. The new tax and fee system applicable to health-care products. Available: http://ansm.sante.fr/var/ansm-site/storage/original/ application/ef5611387712ddfacecca5fda314a25c.pdf. Accessed 2014 Mar 14.
15. Maraninchi D (2013) Notification to the PRAC of a referral under article 31 of Directive 2001/83/EC, Fax number -44 20 75237051. EMA website. Available: http://www.ema.europa.eu/docs/en-GB/document-library/Referrals-document/ Combined-hormonal-contraceptives/Procedure-started/WC500138612.pdf. Accessed 2014 Mar 14.
16. National Institute of Statistics and Economic Studies (Insee) (n.d.) Population by sex and by five year age group. Insee Website. Available: http://www.insee.fr/fr/themes/tableau.asp?reg-id=0&ref-id=NATnon02150. Accessed 2014 Mar 14.
17. Bajos N, Leridon H, Goulard H, Oustry P, Job-Spira N, et al. (2003) Contraception: from accessibility to efficiency. Hum Reprod Oxf Engl 18: 994-999. (Pubitemid 36592040)
18. Bajos N, Bohet A, Le Guen M, Moreau C, the Fecond Survey Team (2012) Contraception in France: new context, new practices? Popul Soc.
19. Oger E (2000) Incidence of venous thromboembolism: a community-based study in Western France. EPI-GETBP Study Group. Groupe d 9 Etude de la Thrombose de Bretagne Occidentale. Thromb Haemost 83: 657-660.
20. Silverstein MD, Heit JA, Mohr DN, Petterson TM, O9Fallon WM, et al. (1998) Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med 158: 585-593. (Pubitemid 28144815)
21. Naess IA, Christiansen SC, Romundstad P, Cannegieter SC, Rosendaal FR, et al. (2007) Incidence and mortality of venous thrombosis: a population-based study. J Thromb Haemost 5: 692-699. doi:10.1111/j.1538-7836.2007.02450.x. (Pubitemid 46563566)
22. Baglin T, Luddington R, Brown K, Baglin C (2003) Incidence of recurrent venous thromboembolism in relation to clinical and thrombophilic risk factors: prospective cohort study. Lancet 362: 523-526. doi:10.1016/S0140-6736(03)14111- 6. (Pubitemid 36976716)
23. Van Hylckama Vlieg A, Helmerhorst FM, Vandenbroucke JP, Doggen CJM, Rosendaal FR (2009) The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. BMJ 339: b2921.
24. Technical Hospitalization Information Agency (ATIH) website. Available: http://www.atih.sante.fr. Accessed 2014 Mar 14.
25. Goldhaber SZ, Visani L, De Rosa M (1999) Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet 353: 1386-1389. (Pubitemid 29192409)
26. Laporte S, Mismetti P, Décousus H, Uresandi F, Otero R, et al. (2008) Clinical predictors for fatal pulmonary embolism in 15,520 patients with venous thromboembolism: findings from the Registro Informatizado de la Enfermedad TromboEmbolica venosa (RIETE) Registry. Circulation 117: 1711-1716. doi:10.1161/CIRCULATIONAHA.107.726232. (Pubitemid 351482603)
27. White RH, Zhou H, Murin S (2008) Death due to recurrent thromboembolism among younger healthier individuals hospitalized for idiopathic pulmonary embolism. Thromb Haemost 99: 683-690. doi:10.1160/TH07-09-0557. (Pubitemid 351694224)
28. Lidegaard O, Nielsen LH, Skovlund CW, Løkkegaard E (2012) Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10. BMJ 344: e2990.
29. Hoffmann B, Gross CR, Jöckel K-H, Kröger K (2010) Trends in mortality of pulmonary embolism - an international comparison. Thromb Res 125: 303-308. doi:10.1016/j.thromres.2009.06.015.
30. Dinger JC, Heinemann LAJ, Kühl-Habich D (2007) The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception 75: 344-354. doi:10.1016/j.contraception.2006.12. 019. (Pubitemid 46551071)
31. IMS-Health (n.d.) MS MIDAS Market Segmentation. IMS Health website. Available: http://www.imshealth.com/deployedfiles/ims/Global/Content/Solutions/ Solutions%20by%20Sector/Pharmaceutical/Mkt-Seg-Brochure.pdf. Accessed 2014 Mar 14.
32. Helmerhorst FM, Rosendaal FR (2013) Is an EMA review on hormonal contraception and thrombosis needed? BMJ 346: f1464.
33. Annex III. Amendments to relevant sections of the summary of product. EMA website. Available: http://www.ema.europa.eu/docs/en-GB/document-library/ Referrals-document/Combined-hormonal-contraceptives/European-Commission-final- decision/WC500160274.pdf. Accessed 2014 Mar 14.