Report from FDA-funded study confirms increased risk of VTEs in users of Yasmin and Yaz

The FDA released the report today from its study of the relative risks of various combined hormonal contraceptives (CHCs). The study compared recently marketed CHCs including Yasmin/Yaz, Ortho Evra and NuvaRing to four older CHCs. The study found a "significantly higher risk of VTE [venous thromboembolic event] relative to low-estrogen comparators.

The study followed 835,826 women ages 10-55 years from January 1, 2001 to December 31, 2007. The FDA considered four primary study endpoints, arterial thrombotic events (which includes arterial myocardial infarction and ischemic stroke), venous thrombolic events, cardiovascular disease mortality and total mortality.

After adjusting for various confounders (such as traditional cardiovascular risk factors as hypertension, hyperlipidemia and diabetes), birth control pills containing drosperinone (including Yasmin and Yaz) were associated with a significantly higher risk of VTE compared to other birth control pills. Further, new users of Yasmin and Yaz were at an even higher risk of both arterial thrombotic events and venous thrombotic events than indviduals who had used other birth control pills previously.

The FDA concluded that the "positive finding regarding VTE risk in this study adds to what is becoming an increasingly clear picture" of the relative risk of VTE in users of Yasmin/Yaz compared to users of other oral contraceptives.