NuvaRing Birth Control Device Can Cause Pulmonary Embolism, Deep Vein Thrombosis, Stroke, And Heart Attack: Part One

Organon's Contraceptive Vaginal Ring Uses Etonogestrel, A Metabolite Of Dangerous Progestin Desogestrel

(Posted by Tom Lamb at DrugInjuryWatch.com)

NuvaRing is a contraceptive vaginal ring that was approved by the FDA in October 2001.  It is manufactured for sale in this country by Organon USA, Inc., based in New Jersey.

NuvaRing has been linked to venous thromboembolic (VTE) events such as pulmonary embolism (PE) and deep vein thrombosis (DVT) as well as ischemic stroke (CVA) and myocardial infarction (MI), or heart attack.

To better understand this emerging drug safety problem, first one needs to know that NuvaRing is a combined contraceptive vaginal ring (CCVR). Ethinylestradiol, or ethinyl estradiol (EE), is the estrogen hormone component and etonogestrel is the progestin, or progestogen, hormone component of NuvaRing.  Over a three-week period, the NuvaRing birth control device releases 15 micrograms of ethinyl estradiol and 120 micrograms etonogestrel per day.

As such, NuvaRing is classified as a low-estrogen-dose contraceptive method that results in low estrogen exposure, which can be good for some women.  On the other hand, this vaginal ring contains a relatively high dose of etonogestrel, which is a metabolite of the dangerous so-called "third-generation" progestin desogestrel (DSG) and, for reasons that we will see, the side effects associated with NuvaRing use can be devastating to a woman.

Going back in time, from the medical journal article “Combination Estrogen–Progestin Oral Contraceptives”, published in October 2003 by The New England Journal of Medicine (NEJM), we learn about two meta-analyses which concluded that the use of low-estrogen oral contraceptives containing the third-generation progestin desogestrel increases the risk of venous thromboembolism, or serious blood clots, more than low-estrogen birth control pills containing the levonorgestrel (a second-generation progestin) — by a factor of 1.5 to 1.8, which most would consider to be a significant increased risk.

More recently, Public Citizen sent to the FDA a February 6, 2007 letter descriptively titled "Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel due to Increased Risk of Venous Thrombosis".  This letter informed the FDA that “Public Citizen has concluded that third generation oral contraceptives essentially double the risk of venous thrombosis [i.e., blood clot] when compared to second generation oral contraceptives.”   This February 2007 Public Citizen letter goes on to set forth some of the existing evidence about a biological mechanism underlying the association between desogestrel and the development of serious blood clots in women.

Insofar that NuvaRing contains a biologically active metabolite of desogestrel, the progestin etonogestrel, it is probable that that this contraceptive vaginal ring likewise increases a woman's risk of developing blood clots and related conditions.  In Part Two of this series about NuvaRing we reveiw some sections of the current NuvaRing package insert, or label, against the backdrop of the above medical information obtained from the NEJM and Public Citizen.