Nuvaring
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<h3 class="entry-header">NuvaRing Birth Control Device Can Cause Pulmonary Embolism, Deep Vein Thrombosis, Stroke, And Heart Attack: Part One</h3>
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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 EstrogenProgestin 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.
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