Venous Thromboembolic Events in Women Using the NuvaRing®.

Venous thromboembolic events (VTEs) are serious adverse effects seen in some women using oral contraceptives. Although the novel vaginal ring, (NuvaRing®) has been reported to be effective and well tolerated, the risks of VTEs are unknown. We report 3 women who developed potentially life-threatening VTEs (2 with pulmonary emboli and 1 inferior vena cava thrombus) while on the NuvaRing®. VTEs occurred 22 days, 3 months and 3 months after NuvaRing® insertion. None had a personal or family history of VTEs. Extensive thrombophilia evaluation showed 1 with heterozygous factor V Leiden and 2 with a transient lupus anticoagulant. 2 had a personal history of multiple miscarriages and all 3 had an elevated body mass index > 26. Searching Pubmed, Ovid and Medline, there have been 10 other reported cases of VTEs, in women using the vaginal ring (see table below). Risk factors reported by other authors include anticardiolipin antibodies, protein S deficiency, heterozygous prothrombin 20210, heterozygous factor V Leiden and prolonged air travel. With limited follow up, the true incidence of VTEs in women using the NuvaRing® is difficult to determine. However, in 2005 the Swedish Medical Products Agency reported a relative incidence of 5.3 cases per 10,000 women years for VTE complications. In summary, we report 3 women who had life-threatening VTEs associated with the use of the NuvaRing®. Longer follow-up of safety studies and post-marketing adverse event reporting are needed to determine VTE risks and incidence while using the NuvaRing®.