Risk of Venous Thromboembolism
Wiegratz and Thaler provide a comprehensive overview of hormonal contraception using the combined oral contraceptive (COC) pill, while also discussing side effects and risks (1). Unfortunately the risks are not comprehensively discussed, and the current state of knowledge is not reflected. With regard to the risk of venous thromboembolism, this may be because of the timing of the article submission.
The authors explain that there are indications of a modified risk for venous thromboembolism as a result of the gestagen component, and that combined preparations including desogestrel, gestodene, and cyproterone acetate entail a higher risk than COCs that include levonorgestrel. This statement is correct, but the authors make no mention at all of the more recent data concerning the risk of venous thromboembolism when using COCs containing drospirenone (2, 3). This is inexplicable since drospirenone-containing COCs are among the most commonly prescribed hormonal contraceptives in Germany (4) and the European Medicines Agency (EMA) has looked into assessing the risk for venous thromboembolism in association with several COCs on the basis of more recent study results as early as in March 2010 and, most recently, in May 2011 (see www.ema.europa, plenary meeting, March 2010 and May 2010).
The EMA classes the risk for COCs containing drospirenone as higher than for COCs containing levonorgestrel, and it assumes that it corresponds to the risk associated with COCs containing desogestrel and gestodene.
In a notice in this issue of Deutsches Ärzteblatt (in German), the risk of venous thromboembolism is the subject of further discussion, as in our opinion the EMA’s assessment should be considered in the individual prescription of any COC.
Prof. Dr. med. Ursula Gundert-Remy
Dr. med. Thomas Stammschulte
Geschäftsstelle der Arzneimittelkommission
der deutschen Ärzteschaft Berlin
Conflict of interest statement
The authors declare that no conflict of interest exists.
|1.||Wiegratz I, Thaler CJ: Hormonal contraception: what kind, when, and for whom? Dtsch Arztebl Int 2011; 108(28–29): 495–506. VOLLTEXT|
|2.||Jick SS, Hernandez RK: 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 2011; 342: d2151. CrossRef MEDLINE|
|3.||Parkin L, Sharples K, Hernandez RK, Jick SS: 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 2011; 342: d2139. CrossRef MEDLINE|
|4.||Schwabe U, Paffrath D (eds.): Arzneiverordnungs-Report 2010. Berlin, Heidelberg: Springer Medizin Verlag, 2010.|