More Reports of Women Who Have Had Serious Blood Clot Problems When Using NuvaRing
Serious Adverse Reactions With This Vaginal Ring Birth Control Device Include Deep Vein Thrombosis (DVT) And Pulmonary Emboli (PE)
(Posted by Tom Lamb at DrugInjuryWatch.com)
An abstract from the annual meeting of the American Society of Hematology (ASH) entitled "Venous Thromboembolic Events in Women Using the NuvaRing®." (Blood -- ASH Annual Meeting Abstracts -- 2007 110: Abstract 3994) concludes with this statement:
Longer follow-up of safety studies and post-marketing adverse event reporting are needed to determine VTE [(venous thromboembolic event)] risks and incidence while using the NuvaRing®.
In arriving at that conclusion, Merrill K. Shum, MD, Kumar Rajagopalan, MD, and Neil A. Lachant, MD, considered three cases they had observed of women using NuvaRing who had developed complications involving blood clots as well as ten other women with serious side effects while using NuvaRing whom they had identified by searching the medical literature:
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....
[T]here 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.
These doctors commented that determining true incidence, or any increased risk, of serious blood clot problems in women using NuvaRing as birth control is difficult to determine at present due to "limited follow up". They did point out, however, the results of one study:
... in 2005 the Swedish Medical Products Agency reported a relative incidence of 5.3 cases per 10,000 women years for VTE complications.
As we reported previously, NuvaRing has been linked to serious side effects caused by dangerous blood clots, such as pulmonary embolism (PE) and deep vein thrombosis (DVT) as well as ischemic stroke (CVA) and myocardial infarction (MI), or heart attack. One can learn more about this emerging drug safety issue in our two-part series:
Accordingly, we agree completely with the authors' conclusion, stated above, that more studies are needed to assess the safety of NuvaRing.
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