NuvaRing® Safety Labeling Changes

NuvaRing® is a vaginal ring contraceptive medication that was approved by the FDA in October 2001. The drug is manufactured by Organon USA, Inc., based in New Jersey, which was acquired by Schering-Plough Corporation in 2007. Since its initial FDA approval and use on the market, NuvaRing® has been linked to serious venous thromboembolic events including blood clots, pulmonary embolism, stroke and myocardial infarction, or heart attack.

FINDINGS ABOUT NUVARING®
NuvaRing® contains a combination of the hormones estrogen (ethinyl estradiol), and progestin (etonogestrel). Etonogestrel is the active metabolite of desogestrel, a synthetic form of the naturally occurring female sex hormone, or progesterone. Desogestrel was the subject of an October 2003 article published in The New England Journal of Medicine, addressing research findings that it can significantly increase the risk of blood clots. Such blood clots, if left untreated, can develop into more serious conditions, including stroke, heart attack, pulmonary embolism (blood clot in the lung), or deep vein thrombosis. The findings from this and other studies were based upon analysis of the effect of contraceptives containing desogestrel, otherwise known as third generation contraceptives, when absorbed by the female body in oral form, or via a pill. In February 2007, the consumer advocacy group Public Citizen petitioned Congress to ban all third generation contraceptives, citing studies that show desogestrel doubles the risk of developing blood clots.

The contraceptive ring is designed to prevent pregnancy by releasing a steady dose of the combination hormones through the walls of the vagina into the bloodstream over the course of 21 days, after which it is to be removed for one week followed by insertion of a new ring. The hormones prevent ovulation, change the cervical mucus to prevent sperm penetration, and thin the lining of the uterus to, theoretically, prevent sperm implantation.

The current label and package insert for NuvaRing®, although amended in 2005 to add additional safety information, fails to explore the potential serious health effects associated with the use of NuvaRing® as a vaginal hormonal contraceptive. Instead, the prescribing information refers to studies conducted on women using third generation oral contraceptives and suggests that adverse reactions that have been associated with the use of combination hormonal contraceptives are “likely to apply to combination vaginal hormonal contraceptives, such as NuvaRing®.” In contradiction of this statement, Organon’s label admits that “[t]here is no epidemiologic data available to determine whether safety and efficacy with the vaginal route of administration of combination hormonal contraceptives would be different than the oral route.” To date, there is no comprehensive study of the long-term health effects of vaginal delivery of the drug combination in NuvaRing®.

We are investigating cases in which individuals that have experienced any of the following side effects associated with the use of the NuvaRing®:
•    Blood Clots
•    Cerebral Hemorrhage
•    Death
•    Deep Vein Thrombosis
•    Myocardial Infarction
•    Pulmonary Embolism
•    Toxic Shock Syndrome
For more information, please contact our office at info@gelmans.com or 973-696-7900.

Further Reading:

Prescription Information
http://www.nuvaring.com/Consumer/Global/prescribingInformation.asp?guid={1D14D479-CF03-410C-BE3C-5D151C3F17BC}&sid=567566619

Wikimedia
http://images.google.com/imgres?imgurl=http://upload.wikimedia.org/wikipedia/commons/thumb/b/bd/NuvaRing_compressed.jpg/200px-NuvaRing_compressed.jpg&imgrefurl=http://en.wikipedia.org/wiki/NuvaRing&h=238&w=200&sz=12&hl=en&start=4&sig2=h9_-pOHfQmkn7A54FVp5PQ&um=1&tbnid=Lv5zvPsM25F83M:&tbnh=109&tbnw=92&ei=M3ThR5uyIImsgQLs_bGRDA&prev=/images%3Fq%3DNuvaRing%26um%3D1%26hl%3Den%26rls%3DPCTA,PCTA:2006-16,PCTA:en%26sa%3DN