The 1995 pill scare revisited: Anatomy of a non-epidemic

Human Reproduction

Volumn 12, Issue 11, 1997, Pages 2347-2357

  Spitzer, Walter O ^a,b  

^a MCGILL UNIVERSITY   (Canada)

^b STANFORD UNIVERSITY   (United States)

Author keywords

Cardiovascular events; Epidemiology; Oral contraceptives; Venous thromboembolism

Indexed keywords

ORAL CONTRACEPTIVE AGENT;

ACUTE HEART INFARCTION; DRUG SAFETY; FEMALE; HUMAN; REVIEW; RISK BENEFIT ANALYSIS; STROKE; THROMBOEMBOLISM;

EID: 0030778429     PISSN: 02681161     EISSN: None     Source Type: Journal    
DOI: 10.1093/humrep/12.11.2347     Document Type: Review

References (84)

1. Ball, M.J., Ashwell, E., Jackson, M. and Gillmer, M.D. (1990) Comparison of two triphasic contraceptives with different progestogens: effects on metabolism and coagulation proteins. Contraception, 41, 363-376.
2. Bloemenkamp, K.W.M., Rosendaal, F.R., Helmerhorst, P.M. et al. (1995) Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestogen. Lancet, 346, 1593-1596.
3. Bolton, H.E., Tapia, P.A., Cabral, H. et al. (1961) Removal of acute coronary thrombus with fybrinolysin - in vivo experiment: a preliminary report on the use of fibnnolytic agents in the treatment of acute thrombosis. J. Am. Med. Assoc., 175, 307-310.
4. Bonnar, J., Daly, L. and Carroll, E. (1987) Blood coagulation with a combination pill containing gestodene and ethinyl estradiol. Int. J. Fertil., 32 (Suppl.), 21-28.
5. Bottiger, L.E. and Westerholm, B. (1971) Oral contraceptives and thromboembolic disease. Acta Med. Scand., 190, 455-463.
6. British National Formulary (1988) British National Formulary. 16th edn, British Medical Association, London, p. 269.
7. British National Formulary (1991) British National Formulary. 22nd edn, British Medical Association, London, p. 272.
8. Cohen, H., Mackie, I.J., Walshe, K. et al. (1988) A comparison of the effects of two triphasic oral contraceptives on haemostasis Br. J. Haematol., 69, 259-263.
9. Cohen, J. (1996) Epidemiological disasters. Hum. Reprod., 11, 689-690.
10. Collet, J.P., Boivin, J.F. and Spitzer, W.O. (1994) Bias and confounding in pharmacoepidemiology. In Strom, B.L. (ed.), Pharmacoepidemiology, John Wiley and Sons Ltd, Chichester, UK, pp. 612-627.
11. European Agency for the Evaluation of Medicinal Products (1997) Position Statement. European Agency for the Evaluation of Medicinal Products, London, 22 January 1997.
12. Farmer, R.D.T. and Preston, T.D. (1995) The risk of venous thromboembolism associated with low oestrogen dose oral contraceptives. J. Obstet. Gynaecol., 15, 195-200.
13. Farmer, R.D.T. and Lawrenson, R. (1996) Utilisation patterns of oral contraceptives in UK general practice. Contraception, 53, 211-215.
14. Farmer, R.D.T., Lawrenson, R.A., Thompson, C.R. et al. (1997) Population based study of risk of venous thromboembolism associated with various oral contraceptives. Lancet, 349, 83-88.
15. Fletcher, A.P., Alkjaersig, N. and Sherry, S. (1962) Fibrinolytic mechanisms and the development of thrombolytic therapy. Am. J. Med., 33, 738-752.
16. Gerstman, B.B., Piper, J.M., Tomita, D.K. et al. (1991) Oral contraceptive estrogen dose and the risk of deep venous thromboembolic disease. Am. J. Epidemiol., 133, 32-37.
17. Goldzieher, J.W. and Rudel, H.W. (1974) How the oral contraceptives came to be developed. J. Am. Med. Assoc., 230, 421-425.
18. Graeff, H., Battis, P., Hafter, R. and Zander, J. (1977) Evaluation of hypercoagulability in users of oral contraceptives. Klin. Wochensch., 55, 175-179.
19. Gramolini, R., Perrone. G., Calzolari, E. et al. (1987) Evaluation of some coagulation tests in women using low-dose oral contraceptives. Pat. Clin. Ost Gin., 15, 307-312.
20. Guillebaud, J. (1993) Contraception, Your Questions Answered. Churchill Livingstone, Edinburgh, UK, pp. 167-175.
21. GUSTO Investigators (1993) An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N. Engl. J. Med., 329, 673-682.
22. Heinemann, L.A.J., Lewis, M.A., Assman, A. et al. (1996) Could preferential prescribing and referral behaviour of physicians explain the elevated thrombosis risk found to be associated with third generation oral contraceptives? Pharmacoepidem. Drug Safety 5, 285-294.
23. Heinemann, L.A.J., Lewis, M.A., Guggenmoos-Holtzman, I. et al. (1997) Thromboembolic stroke in young women. Br. Med. J., in press.
24. Hope, S. (1996) 12% of women stopped taking their pill immediately they heard CSM's warning. Lancet, 312, 576.
25. Jamin, C. and De Mouzon, J. (1996) Selective prescribing of third generation oral contraceptives (OCs). Contraception. 54, 55-56.
26. Jick, H., Jick, S.S., Gurewich. V. et al. (1995) Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestogen components. Lancet, 346, 1589-1593.
27. Jick, H., Jick, S., Meyers. M.W. and Vasilakis, C. (1996a) Risk of acute myocardial infarction and low-dose combined oral contraceptives. Lancet, 347, 627-628.
28. Jick, H., Jick, S., Myers, M.W. and Vasilikis, C. (1996b) Authors reply. Lancet, 47, 548.
29. Johannisson. E. (1996) On behalf of the International Committee for Research in Reproduction. Lancet, 347, 258.
30. Kjaer, A., Lebech, A.M., Borggaard. B. et al. (1989) Lipid metabolism and coagulation of two contraceptives: correlation to serum concentrations of levonorgestrel and gestodene. Contraception, 40, 665-673.
31. Kloosterboer, H.J., Van Wayjen, R.G.A. and Van den Ende, A. (1987) Effects of three low-dose oral contraceptive combinations on sex-hormone binding globulin, corticosteroid binding globulin and antithrombin III activity in healthy women: two monophasic desogestrel combinations (containing 0.020 or 0.030 mg ethinylestradiol) and one triphasic levonorgestrel combination. Acta Obstet. Gynecol. Scand., 144, 41-44.
32. Koster, T. and Rosendaal, F.R. (1994) Factor VII and fibrinogen levels as risk factors for venous thrombosis. A case control study of plasma levels and DNA polymorphisms. Thromb. Haemost., 71, 719-722.
33. Leader, A. (1996) The public warnings on cardovascular disease and third-generation oral contraceptives were not justified. Hum. Reprod., 11, 692-693.
34. Lewis, M., Spitzer, W.O., Heinemann, L.A.J. et al. (1997) Lowered risk of dying of heart attack with third generation contraceptives may offset risk of dying of thromboembolism. Br. Med. J., 315, 679-680.
35. Lewis, M.A., Heinemann, L.A.J., MacRae, K.D. et al. (1996a) The increased risk of venous thromboembolism and the use of third generation progestagens: role of bias in observational research. Contraception, 54, 5-13.
36. Lewis, M.A., Spitzer, W.O., Heinemann, L.A.J. et al. (1996b)Third generation oral contraceptives and risk of myocardial infarction: an international case-control study. Br. Med. J., 312, 88-90.
37. Lidegaard, O. (1993) Oral contraceptives and risk of a cerebral thromboembolic attack: results of a case-control study. Br. Med. J., 306, 956-963.
38. Lidegaard, O. (1996) Oral contraceptives and venous thromboembolism: an epidemiological review. Eur. J. Contr. Reprod. Health, 1, 13-20.
39. Lidegaard, O. (1997) The influence of thrombotic risk factors when oral contraceptives are prescribed. A control only study. Acta Obstet. Gynecol. Scand., 76, 252-260.
40. Lidegaard, O. and Kreiner, S. (1997) Cerebral thromboembolism and oral contraceptives: a case-control study. [Abstr. no. 297] In 13th International Conference on Phamacoepidemiology, Orlando, FL, August 1988.
41. Lidegaard, O., Edstrom, B. and Kreiner, S. (1997) Venous thromboembolism and oral contraceptives: a case-control study. [Abstr. no. 298] In 13th International Conference on Pharmacoepidemiology, Orlando, FL, August 1988. International Society for Pharmacoepidemiology (ISPE).
42. Machin, S.J., Mackie, I.J., Walshe, K. and Gillmer, M.D. (1987) Hemostatic changes induced by two low dose triphasic oral contraceptives. Thromb. Haemostasis, 58, 279.
43. Meade, T.W. (1977) Haemostatic, lipid and blood-pressure profiles of women on oral contraceptives containing 50 mcg or 30 mcg oestrogen. Lancet, ii, 948-951.
44. Melis, G.B., Fruzzetti, F., Nicoleffi, I. and Ricci, C. (1991) A comparative study on the effects of a monophasic pill containing desogestrel plus 20 μg ethinylestradiol, a triphasic combination containing levonorgestrel and a monophasic combination containing gestodene on coagulatory factors. Contraception, 43, 23-31.
45. National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group (1995) Tissue plasminogen activator for acute ischemic stroke. N. Engl. J. Med., 333, 1581-1587.
46. Norris, L.A. and Bonnar, J. (1996) The effect of oestrogen dose and progestogen type on haemostatic changes in women taking low dose oral contraceptives. Br. J. Obstet. Gynaecol., 103, 261-267.
47. Office for National Statistics (1997) Legal Abortions, June Quarter 1996. ONS monitor AB 97/1. Office for National Statistics, London, UK.
48. Omsjo, I.H., Oian, P., Maltau, J.M. and Osterund, B. (1989) Effects of two triphasic oral contraceptives containing ethinyl estradiol plus levonorgestrel or gestodene on blood coagulation and fibrinolysis. Acta Obstet. Gynecol. Scand., 68, 27-30.
49. Petitti. D.B., Sidney, S., Bernstein, A. et al. (1996) Stroke in users of low-dose oral contraceptives. N. Engl. J. Med., 335, 8-15.
50. Plu-Bureau, G., Amiral, J., Guize, L. and Scarabin. P.Y. (1996) Safety of combined oral contraceptive pills. Lancet, 347, 549.
51. Porter, J.B., Hunter, J.R., Jick, H. and Stergachis, A. (1985) Oral contraceptives and nonfatal vascular disease. Obstet. Gynecol., 66, 1-4,
52. Poulter. N.R., Farley, T.M.M., Chang. C.L. et al. (1996) Safety of combined oral contraceptive pills. Lancet, 347, 547.
53. Prasad. R.N.V., Koh, S. and Ratnam, S.S. (1989) Effects of three types of combined OC pills on blood coagulation, fibrinolysis and platelet function. Contraception, 39, 369-384.
54. Rabe. T., Runnebaum, B., Kohlmeier, M. et al. (1987) Clinical and metabolic effects of gestodene and levonorgestrel. Int. J. Fertil., 32 (Suppl.), 29-44.
55. Rákóczi, I., Gero, G., Demeter, J. and Gati, I. (1985) Comparative metabolic effects of oral contraceptive preparations containing different progestogens. Effects of desogestrel + ethinylestradiol on the haemostatic balance. Arzneimittelforschung/Drug Res., 35, 630-633.
56. Refin, H., Kjaer, A., Lebech, A.M. et al. (1990) Metabolic changes during treatment with two different progestogens. Am. J. Obstet. Gynecol., 163, 74-77.
57. Rosing, J., Tans, G., Nicolaes, G.A.F. et al. (1997) Oral contraceptives and venous thrombosis: different sensitivities to activated protein C in women using second-and third-generation oral contraceptives. Br. J. Haematol., 97, 233-238.
58. Royal College of General Practitioners (1967) Oral contraception and thromboembolic disease. J. R. Coll. Gen. Pract., 13, 267-279.
59. Royal College of General Practitioners (1974) Oral Contraceptives and Health. Pitman Medical, London, UK.
60. Royal College of General Practitioners (1978) Oral contraceptives, venous thrombosis and varicose veins: Royal College of General Practitioners' Oral Contraceptive Study. J. R. Coll. Gen. Pract., 28, 203-209.
61. Sartwell, P.E., Masi, A.T., Arthes, F.G. and Greene, G.R. (1969) Thrombosis and oral contraceptives: a case control study. Am. J. Epidemiol., 90, 365-380.
62. Schwingl, P.J. and Shelton, J. (1997) Modeled estimates of myocardial infarction and venous thromboembolic disease in users of second and third generation oral contraceptives. Contraception, 55, 125-129.
63. Shah. I.H. (1994) The advance of the contraceptive revolution. World Health Stat. Q., 47, 9-15.
64. Sirtori, C.R., Calabresi, L., Franceschini, G. et al. (1990) Comparison of the lipoprotein and haemostatic changes after a triphasic and a monophasic low dose oral contraceptive in premenopausal middle-aged women. Atherosclerosis, 84, 203-211.
65. Skjeldestad, F.E. (1997) Increased number of induced abortions in Norway after media coverage of adverse vascular events from the use of third-generation oral contraceptives. Contraception, 55, 11-14.
66. Spitzer, W.O., Lewis, M.A., Heinemann, L.A.J. et al. (1996) Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. Br. Med. J., 312, 83-88.
67. Stadel, B. (1981) Oral contraceptives and cardiovascular disease. N. Engl. J. Med., 305, 612-618.
68. Statistisches bundesamt. (1995 and 1996) Schwangerschaftsabbruchsstatistik. Statistisches bundesamt, Germany.
69. Suissa, S., Blais, L., Spitzer, W.O. and Cusson, J. (1997) First-time use of newer oral contraceptives and the risk of venous thromboembolism. Contraception, 56, 128-132.
70. TIMI Study Group (1985) The thrombolisis in myocardial infarction (TIMI) trail. Phase 1 findings. N. Engl. J. Med., 312, 932-936.
71. Van Lunsen, H.W. (1996) Recent oral contraceptive use patterns in four European countries: evidence for selective prescribing of oral contraceptives containing third generation progestogens. Eur. J. Contracept. Reprod. Health Care, 1, 39-45.
72. Vandenbroucke, J.P and Rosendaal, F.R. (1997) End of the line for 'third-generation' controversy? Lancet, 349, 1113-1114 [Responses in 349, 1621-1623.]
73. Vandenbroucke, J.P., Bloemenkamp, K.W.M., Helmerhorst, F.M. and Rosendaal, F.R. (1996) Mortality from venous thromboembolism and myocardial infarction in young women in the Netherlands. Lancet, 348, 401-402 [Responses in 348, 1095-1097.]
74. Vekemans, M., Grippa, J., Capel, P. and Fondu, P. (1987) The effect of two low-dose contraceptives containing ethinylestradiol and desogestrel or dnorgestrel on blood clotting factors. Curr. Ther. Res., 42, 1109-1118.
75. Vessey, M.P. (1988) Epidemiological studies of lower dose oral contraceptives. Data presented at XII World Congress of Gynecology and Obstetrics. Rio de Janeiro, October 26.
76. Vessey, M.P. and Doll, R. (1968) Investigation of relation between use of oral contraceptives and thromboembolic disease. Br. Med. J., 2, 199-205.
77. Vessey, M.P. and Doll, R. (1969) Investigation of relation between use of oral contraceptives and thromboembolic disease. A further report. Br. Med. J., 2, 651-657.
78. Westhoff, C. (1996) Oral contraceptives and venous thromboembolism: should epidemiological associations drive clinical decision making? Contraception, 54, 1-3.
79. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception (1995a) Effect of different progestogens in low oestrogen oral contraceptives on venous thromboembolic disease. Lancet, 346, 1582-1588.
80. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception (1995b) Ischemic stroke and combined oral contraceptives: results of an international, multicentre, case-control study. Lancet, 348, 498-505.
81. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception (1996) Haemorrhagic stroke, overall stroke risk, and combined oral contraceptives: results of an international, multicentre. case-control study. Lancet, 348, 505-510.
82. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception (1997) Acute myocardial infarction and combined oral contraceptives: results of an international multicentre case-control study. Lancet, 349, 1202-1209.
83. Winkler, U.H., Schindler, A.E., Endrikat, J. and Dusterberg, B. (1996) A comparative study of the effects of the hemostatic system of two monophasic gestodene oral contraceptives containing 20 μg and 30 μg ethinylestradiol. Contraception, 53, 75-84.
84. Zichella, L. (1987) Metabolic evaluation of women using three different oral contraceptives: a comparison. In Volpe, A.R. and Vacchinetti, F. (eds), Gynecological Endocrinology. Parthenon Publishing Group, Carnforth, UK, pp. 399-403.