In Addition, The New Package Insert No Longer States It Is Unknown If NuvaRing Has A Different Blood Clot (VTE) Risk Than Some Birth Control Pills
On October 4, 2013 the FDA approved some revisions to the Prescribing Information for NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring), which first became available in 2001 for women in the U.S.
The changes to the NuvaRing label can be found in the Warnings and Precautions section, specifically at 5.1 Thromboembolic Disorders and Other Vascular Problems, starting at page 6 of the 2013 NuvaRing label accessed 11/6/13 on the FDA's website. Here is some of the "new" information about the safety profile of NuvaRing found in the revised package insert:
Two epidemiologic studies [footnotes 1, 2, and 3, here] that assessed the risk of [venous thromboembolic event (VTE)] associated with the use of NuvaRing are described below.
In these studies, which were required or sponsored by regulatory agencies, NuvaRing users had a risk of VTE similar to COC users (see Table 1 for adjusted hazard ratios). A large prospective, observational study, the Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC), investigated the risk of VTE for new users, and women who were switching to or restarting NuvaRing or COCs in a population that is representative of routine clinical users. The women were followed for 24 to 48 months. The results showed a similar risk of VTE among NuvaRing users (VTE incidence 8.3 per 10,000 WY) and women using COCs (VTE incidence 9.2 per 10,000 WY). For women using COCs that did not contain the progestins desogestrel (DSG) or gestodene (GSD), VTE incidence was 8.9 per 10,000 WY.
A retrospective cohort study using data from 4 health plans in the US (FDA-funded Study in Kaiser Permanente and Medicaid databases) showed the VTE incidence for new users of NuvaRing to be 11.4 events per 10,000 WY, for new users of a levonorgestrel (LNG)-containing COC 9.2 events per 10,000 WY, and for users of other COCs available during the course of the study1 8.2 events per 10,000 WY.
The footnotes 1, 2, and 3 shown above can be found in the References section of this new NuvaRing label, at page 18 and set forth below:
- 1. Dinger, J et. al., Cardiovascular risk associated with the use of an etonogestrel-containing vaginal ring. Obstetrics & Gynecology 2013; 122(4): 800-808.
- 2. Sidney, S. et. al., Recent combined hormonal contraceptives (CHCs) and the risk of thromboembolism and other cardiovascular events in new users. Contraception 2013; 87: 93–100.
- 3. Combined hormonal contraceptives (CHCs) and the risk of cardiovascular endpoints. Sidney, S. (primary author)http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf, accessed 23-Aug-2013.
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Some less obvious changes to the 2013 NuvaRing Prescribing Information have to do with this paragraph taken from the previous version of the NuvaRing label:
Several epidemiology studies indicate that third generation oral contraceptives, including those containing desogestrel (etonogestrel, the progestin in NuvaRing®, is the biologically active metabolite of desogestrel), are associated with a higher risk of venous thromboembolism than certain second generation oral contraceptives. In general, these studies indicate an approximate twofold increased risk, which corresponds to an additional one to two cases of venous thromboembolism per 10,000 women-years of use. However, data from additional studies have not shown this two-fold increase in risk. It is unknown if NuvaRing® has a different risk of venous thromboembolism than second generation oral contraceptives. [emphasis added]
Most notably, the last sentence of that paragraph is not included in the new NuvaRing label.
Here are some of our earlier articles about medical studies that considered the issue of whether NuvaRing increases the risks of blood clots that can cause a deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack (MI), and/or stroke (CVA):
We will continue to monitor the safety profile of NuvaRing as well as the related products liability litigation involving more than 1500 personal injury and wrongful death cases.