Is There A Safety Problem With NuvaRing And Why Are Lawsuits Being Filed?
Does Organon Fail to Warn Sufficiently About Possibly Dangerous Progestin Etonogestrel, Which Can Cause Blood Clots?
August 2008 Update: NuvaRing MDL Created And Assigned To Judge Sippel
U.S. District Judge Rodney W. Sippel will hear presentations on (1) the Plaintiffs’ theory about how the NuvaRing causes an increased risk of serious blood clots, and (2) drug company’s contention that the NuvaRing is not a dangerous nor unsafe birth control method at a one-day “Science Day” scheduled for December 1, 2009.
NuvaRing is a contraceptive vaginal ring that releases 15 micrograms of ethinyl estradiol and 120 micrograms of etonogestrel per day. Each ring is used for one cycle, comprising 3 weeks continuous use of the ring followed by a 1-week ring-free period. It is manufactured by by Organon USA, Inc. and was approved in October 2001 by the FDA for sale in the U.S.
As a result of case reports made by women and their doctors, NuvaRing use is associated with serious side effects resulting from blood clots, such pulmonary embolism (PE) and deep vein thrombosis (DVT) as well as strokes and heart attacks, with some events resulting in death.
One suggested reason that NuvaRing might cause these blood clots is because this vaginal ring contains etonogestrel, which is a metabolite of the possibly dangerous progestin desogestrel. As background, desogestrel is classified as a "third generation" progestin.
In February 2007 the consumer advocacy group Public Citizen sent to the FDA a letter entitled "Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel due to Increased Risk of Venous Thrombosis" which included this information:
Based on the epidemiologic evidence from these studies, including two
meta-analyses, Public Citizen has concluded that third generation oral contraceptives
essentially double the risk of venous thrombosis when compared to second generation oral
contraceptives. The FDA acknowledged this in a statement in November 1995 stating “new
studies indicate about a two-fold increase in the risk of venous blood clots associated
with products containing desogestrel.” The risk essentially translates to about 1.5
additional incidents of thromboembolic disease per 10,000 women-years.
The current version of the NuvaRing Physician's Insert, or label, contains some warnings about the risk of blood clots, or venous thrombosis, but none of the warning is bolded nor does the NuvaRing label have a so-called "black box" warning. A similar non-bolded warning currently appears on Organon's third generation combination oral contraceptive pill Desogen, known elsewhere around the world as Marvelon, both of which combine 150 micrograms of the progestin desogestrel with 30 micrograms of the estrogen ethinylestradiol.
Given that serious blood clot-related conditions like pulmonary embolism (PE) and deep vein
thrombosis (DVT) -- not to mention strokes and heart attacks -- can lead to significant
functional disability and possibly death, this level of warning on the current NuvaRing
label seems insufficient. Moreover, one may allege that the current label constitutes a so-called
"failure to warn" by Organon in light of the existing evidence about a biological mechanism underlying the association between etonogestrel, as a desogestrel metabolite, and the increased risk of developing blood clots.
For this reason, in July 2007 alone more than 30 lawsuits were filed in New Jersey against
the pharmaceutical company Organon asserting that NuvaRing caused a stroke-induced death, cases of pulmonary embolism, and other serious blood clot related injuries in women using this contraceptive vaginal ring.
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