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Should 3rd Generation Birth Control Pills be Banned? - Petition to Ban 3rd Generation OCs due to Increased Clotting Risk
Marie B. Walker
Henry I. Bussey, Pharm.D., FCCP, FAHA
March, 2007
An organization known as Public Citizen has submitted a petition to the FDA requesting an immediate ban of third generation oral contraceptives containing desogestrel "due to the approximately doubled risk of venous thrombosis... and lack of evidence of clinical benefit as compared to the second generation oral contraceptives." The group cites 14 studies indicating that third generation oral contraceptives carry a risk of venous thrombosis 1.5 to 2.4 times greater than that of first and second generation oral contraceptives. At the bottom of this page, we have provided links to the abstract or full text (depending on availability) of each of the studies cited in the petition.
You can also review the entire petition on the website of Public Citizen at http://www.citizen.org/publications/release.cfm?ID=7503.
What is a 3rd Generation Oral Contraceptive?
Second and third generation oral contraceptives are birth control pills that contain two types of hormones: (1) estrogen and (2) progestin. The difference between second and third generation pills is the type of progestin contained in the pill. Second generation pills contain norgestrel, levonorgestrel, or norgestimate. Third generation pills contain desogestrel or gestodene (outside of the US). According to this petition, the desogestrel is responsible for the increased clotting risk associated with third generation oral contraceptives.
Who is Behind this Petition?
The petition indicates that "Public Citizen, representing more than 100,000 consumers nationwide" is submitting the petition to the FDA. According to the group's own website, Public Citizen is:
"a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts."
The petition also is signed by 4 medical doctors (MDs), two of whom also hold MPH degrees (Masters in Public Health). The 4 MDs who signed this petition are:
Jay Parkinson, MD, MPH
Sylvia Park, MD, MPH
Sydney M. Wolfe, MD
Frits Rosendaal, MD
An Opposing View from Lisa Moore, MD
I (Marie) recently had the opportunity to attend a presentation on women's clotting issues at a patient education seminar hosted by the National Alliance for Thrombosis and Thrombophilia. Dr. Lisa Moore discussed a number of issues including the use of oral contraceptives and their clotting risk. I asked Dr. Moore for her opinion on the petition to ban 3rd generation oral contraceptives and she was kind enough to put her thoughts in writing for ClotCare. Click here to learn why Dr. Moore does not support the proposed ban on 3rd generation oral contraceptives..
References Cited in the Petition
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Anderson FA, et al. (1991). A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT study. Arch Intern Med, 151:933-938.
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Kyrle PA, Eichinger S. (2005). Deep Vein Thrombosis. Lancet, 365:1163-1174.
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Prandoni P, et al. (2004). Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med, 141:249-256.
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Brandjes DP, et al. (1997). Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet, 340:759-762.
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Christiansen SC, Cannegieter SC, Koster T, Vandenbroucke JP, Rosendaal FR. (2005). Thrombophilia, clinical factors, and recurrent venous thrombotic events. JAMA, 293: 2352-2361.
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Farley TMM, Meirik O, Chang CL, Marmot MG, Poulter NR, for the World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception Investigators. (1995). Effect of different progestagens in low oestrogen oral contraceptives on venous thrombo-embolic disease. Lancet, 346:1582-1588.
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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, 346:1589-93.
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Bleomenkamp KWM, Rosendaal FR, Helmerhorts FM, Buller HR, Vandenbroucke JP. (1995). Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestogen. Lancet, 346:1593-6.
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Spitzer, WO. (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(7023):83-8.
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Farmer, R. (1997). Population-based study of risk of venous thromboembolism associated with various oral contraceptives. Lancet, 349(9045):83-8.
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Farmer, R. (1998). The risks of venous thromboembolic disease among German women using oral contraceptives: a database study. Contraception, 57(2):67-70.
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Lidegaard, O. (1998). Oral contraceptives and venous thromboembolism. A case-control study. Contraception, 57(5):291-301.
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Bloemenkamp KWM, Rosendaal FR, Buller HR, Helmerhorst FM, Colly LP, Vandenbroucke JP. (1999). Risk of venous thrombosis with use of current low-dose oral contraceptives is not explained by diagnostic suspicion and referral bias. Arch Intern Med, 159:65-70.
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Jick H, Kaye JA, Vasilakis-Scaramozza C, Jick SS. (2000). Risk of venous thromboembolism among users of third generation oral contraceptives compared with users of oral contraceptives with levonorgestrel before and after 1995: cohort and case control analysis. BMJ, 321:1190-1195.
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Andersen BS, Olsen J, Nielsen GL, et al. (1998). Third generation oral contraceptives and heritable thrombophilia as risk factors of non-fatal venous thromboembolism. Thromb Haemost, 79:28-31.
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Heinemann LAJ, Lewis MA, Assmann A, Thiel C. (2002). Case-control studies on venous thromboembolism: bias due to design? A methodological study on venous thromboembolism and steroid hormone use. Contraception, 65:207-214.
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Herings RMC, Urquhart J, Leufkens HGM. (1999). Venous thromboembolism among new users of different oral contraceptives [published correction appears in Lancet.1999;354:1478]. Lancet, 354:127-128.
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Farmer R, Lawrenson RA, Todd J-C, et al. (2000). A comparison of the risks of venous thromboembolic disease in association with different combined oral contraceptives. Br J Clin Pharmacol, 49:580-590.
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Lidegaard Ø, Edstrom MB, Kreiner S. (2002). Oral contraceptives and venous thromboembolism: a five-year national case-control study. Contraception, 65:187-196.
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Parkin L, Skegg DCG, Wilson M, Herbison GP, Paul C. (2000) Oral contraceptives and fatal pulmonary embolism. Lancet, 355:2133-2134.
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Kemmeren, JM. (2001). Third Generation oral contraceptives and risk of venous thrombosis: meta-analysis. BMJ, 323(7305): 131 - 139.
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Hennessy S, Berlin JA, Kinman JL, Margolis DJ, Marcus SM, Strom BL. (2001). Risk of venous thromboembolism from oral contraceptives containing gestodene and desogestrel versus levonorgestrel: a meta-analysis and formal sensitivity analysis. Contraception, 64:125-133.
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World Health Organization. (1995). Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case control study. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Lancet, 346:1575-1582.
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Rosing, J. (2001). Oral contraceptives, thrombosis and haemostasis. European Journal of Obstetrics & Gynecology and Reproductive Biology, 95:193-197.
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Tans, G. (2000). A randomized cross-over study on the effects of levonorgestrel- and desogestrel-containing oral contraceptives on the anticoagulant pathways. Thromb. Heamost, 84(1):15-21.
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Jick SS, Vasilakis C, Jick H. (1998). Pregnancies and terminations after 1995 warning about third-generation oral contraceptives. Lancet, 351:1404-1405.
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Allison, C. (1996).Aftermath of the oral contraceptive scare. Br. J. Sex. Med. Nov/Dec, 13-16.
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Martin RM, Hilton SR, Kerry SM. (1997). The impact of the October 1995 'pill scare' on oral contraceptive use in the United Kingdom: analysis of a general practice automated database. Family Practice, 14:279-284.
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De Vries CS, Van den Berg PB, De Jong-van den Berg LTW. (1998). Oral Contraceptive use before and after the latest pill scare in the Netherlands. Contraception, 57: 247-249.
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De Jong-van den Berg L, Tobi H, Bijker B, Van den Berg P. (2003). Influence of the third generation pill controversy on prescriptions for oral contraceptives among first time users: population based study. BMJ, 326: 254.
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Vandenbroucke JP, Rosing J, Bloemenkamp KWM, Middeldorp S, Helmerhorst FM, Bouma BN, Rosendaal FR. (2001). Oral Contraceptives and the Risk of Venous Thrombosis. N Engl J Med, 344:1527-1535.
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