Statement on combined hormonal contraceptives containing third or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism

Dowrloaded from jfprhc,bmj.corn on November 7,2013 - Punished by grouytnni com =.::'«l SVVIU E ‘ME WT For nurnbened affiliations see end of article. Correspondence to Professor Dr Johan res Bitzer. Chief Physician and Chairman Department of Obnettics and Gynaecology. University Hospital Basel. Basel. Switzerland; JohartnesBitzer@usb.cl‘. Received IS March 2013 Accepted 18 March 2013 To cite: Bitzer J Amy J-J. Beerttmizer R. et al. Joumai of Fanfly Planning and Reproductive Health C are Published Online First lnlease include Day Month Year] doi: 10. l l36lifptl1(-20l3- 100624 Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism Johannes Bitzer Cosignatories Jean-Jacques Amy,‘ Rob Beerthuizen,2 Martin Birkhauser,3 Teresa Bombas,“ Mitchell Creinin,5 Philip D Darney,5 Lisa Ferreira Vicente,’ Kristina Gemzell-Danielsson,° Bruno lmthurn,9 Jeffrey T Jensen,” Andrew M Kaunitz,“ Ali Kubba,” Medlard M Lech,” Diana Mansour,” Gabriele Merki,” Thomas Rabe,‘6 Katarina Sedlecki,” David Serfaty,‘8Jact1ues Seydoux,” Lee P Shu|man,2° Regine Sitruk-Ware, ‘ Sven O Skouby,” Anne Szarewski, James Trussell,” Carolyn Westhoffzs A NEW PILL SCARE? HOW DID IT COME ABOUT AND HOW SHOULD WE TACKLE IT? The cotttroversy around the combined hormonal contraceptives ((IH(,'s) of the so-called third (containing gestodene or desogestrel) and fourth generation (cott- raining drospirenone. DRSP) lt-as reached .1 highly emotional political dimension in which all those who “are prol'essionall_v responsible for women's health are involved: the national health authorities, the pltarrnaceutical companies, the pro- fessional orgartis-ations, the prescrihers. the media and the public (i.e. the current or potential users of CH(Is). The — initially scientific — controversy has now led to a ptthlic health dispute that culminated in the decision of the Frenelt '.1tltht)ritlc's to withdraw the com hination containing etltinylestradiol (EE) and cyproterone acetate (CPA) from the market. The potential impact of this measure, namely the loss of confidence in .1/I (Ill(.'s. could be quite serious. WHAT TRIGGERED THIS CRISIS? Several re;.',is‘tr_v~hasei.l studies published in the Britr'.~‘l2 .\ledic.tl Irirrrmtl. partictilarlv 23 the one based on the Danish Registry. indicated that there is an increased risk of venous thrombiternholism (VTE) asso- ciated with the intake of third- and liounh-generation combined oral contra- ceptives ((ZO('.s) compared to prepara- tions containing the progestogen le\'onorges‘trel (I-.\l(§).q5 The relative risk (RR) was around 2. and the absolute attributable risk was estimated to be (dependent on the background preva- lence rate) between .2 to 8 per ll) llllll users per year.q A very recent systentatic review and meta-anal_vsis of the possible link between treatment with CHCs and VTF. con- cluded that. in this regard. (I) (3H(Zs cort- taining I.N(} or norgestimate were the safest. (.1) those containing desogestrel. DRSI’ or (IPA were associated with a sig- ttillC.‘tI1tl_\' ltiglter risk than (IH(Is contain- ing LNG, and (3) the aup,ntented risk of VTE found for pills containing gestodene compared to (l(.)(Ls with L\'(; appeared to be smaller than in earlier s'tttcllcs.7 These resultsq contrast with those of published prospective cohort studies. sponsored by It’-a_ver He-altlt(.are. at the request of the European Medicitte Bitzer J et J Journal offamily Planting and Reolodzcme Health (.19 20‘~3;0:'-at doizt 0.’ ’-36Ii?prh: 2073 ‘0062-1 1