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.

Comments

[Tom Lamb]

I appreciate your effort and time as regards sharing with us (from the hospital) what you are going through now, and have been through during recent months, due to your use of the NuvaRing birth control product.

You tell a compelling story about why the serious side effects associated with NuvaRing must be brought to the attention of women and their doctors. As you know, unfortunately, ignorance about the association between NuvaRing and pulmonary embolisms (PE), or deep vein thromobosis (DVT), can result in a failure to timely diagnose and treat serious side effects that can be fatal in some instances.

We wish you a speedy and full recovery, and I am sure that what you have shared here with others will help get the word out about NuvaRing side effects.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Jessica]

I am an 18 year old girl. I am a nationally ranked competitive swimmer, and I have never smoked in my life nor have I ever had a sip of alcohol. And I am currently being hospitalized for the 5+ pulmonary embolisms that I developed over an 8 month period regular use of the Nuvaring.

I was misdiagnosed with a chest wall tear in the emergency room when I first experienced severe chest pain. The doctors insisted I must have been kicked during a water polo game, but the pain seemed unrelated to an event that I couldn't recall.

Three months later, I had the exact same symptoms, which were again, dismissed by my family doctor but I entered a different emergency room and was almost immediatenly informed of my pukmonary embolisms.

I spent a week in the hospital last week, and I had to be readmitted last night due to low blood clotting levels.

My concern is for the next girl who is told to ignore her severe chest pains and is sent home and is told that it's normal to not be able to lay down for a week. Doctors need to know about this risk and they need to know that it is possible for younger girls to develop PE if they are on a birth control containing estrogen.

[Tom Lamb]

I appreciate you sharing your unfortunate medical experience with us and for the caution you urge as regards this unsafe birth control device / drug.

As you probably know from your research, there are products liablity lawsuits being filed on behalf of women who have suffered serious side effects due to their use of NuvaRing.

I would be interested in speaking with you about a possible legal case if you are not already represented by an attorney. My toll-free number is 800-426-9535; my email address is ThomasJLamb@DrugInjuryLaw.com

We represent women who have developed deep vein thrombosis (DVT) and pulmonary embolism (PE) in these lawsuits against Organon, the maker of the NuvaRing product.

Best of luck to you in all aspects, and thanks for reading Drug Injury Watch.

Tom Lamb

[Toni Milbourn]

I was hospitalized July 26 2007 with several pulmonary embolisms in my lungs, I am a 53 year old woman and a non smoker that was taking Nuvaring for menopause symptoms. I was in intensive care for 5 days and in the hospital for 2 I was given the life threatening clot buster and had several blood tests eventually confirming the true fact that it was actually the nuvaring that caused these clots confirmed by a group of hemotologists after several series of blood test over these last few months. Please be cautious in using this drug It is a dangerous one from reading several blogs about this drug I am just extremly thankful to be alive. Toni

[Tom Lamb]

Sorry to hear about the serious side effect you experienced while using NuvaRing birth control.

Some doctors who have treated our clients hospitalized for a pulmonary embolism / emboli (PE) and for deep vein thrombosis (DVT) link their conditions to NuvaRing, while other doctors do not do so for various reasons.

Please understand that a legal case can be successful even if the treating doctor is unaware that NuvaRing has been associated with an increased risk of PE and DVT events in healthy women like you.

To the extent you want to "raise awareness" with the FDA and Organon, the drug company -- as well as other women using NuvaRing -- you may want to report your apparent serious side effect to the FDA's MedWatch program. Here is a link to an information page about how to submit a MedWatch report:

http://www.druginjurylaw.com/medwatch-report.html

If you want to find out more about a legal compensation claim as regards your possible NuvaRing-related pulmonary emboli (PE) event, here is a link to our NuvaRing information page at DrugInjuryLaw.com:

http://www.druginjurylaw.com/NuvaRing-information.php

In closing, know that we would be interested in investigating your possible NuvaRing lawsuit, as it looks like a probable case from this limited information.

Either way, thanks for sharing your experience with others and for reading Drug Injury Watch.

Tom Lamb

[Kim]

I was recently hospitalized for pulmonary embolism (actually emboli in both lungs). My only "risk factor" was that I was using Nuvaring. I am an otherwise healthy 25 year old female (nonsmoker). There was another female who was diagnosed with a DVT (clot in the leg) the same day I was hospitalized, who was also on Nuvaring.
Doctors and the manufacturers need to become more aware about this, if nothing else than to warn patients of the risks and symptoms so that the clot does not lead to death. My doctor didn't think Nuvaring was even a high enough dose of hormone to cause clots, and many others may also think so. In fact, at first I was sent home with antibiotics (because the symptoms of PE are a lot like pneumonia-shortness of breath, chest pain). If I wouldn't have called him that next morning telling him of the severe pain and more difficulty breathing, he may not have sent me in to get checked for a PE (it is not common in young people, so doctors usually don't think of it), and it could have been fatal.

[Tom Lamb]

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, one may allege that the current NuvaRing package insert, or label, constitutes a so-called "failure to warn" by the pharmaceutical company Organon.

For this reason, lawsuits have been filed against Organon concerning cases of pulmonary embolism and other serious blood clot related injuries in women using this contraceptive vaginal ring.

You can learn more about why NuvaRing lawsuits are being filed against Organon on this page over at our Drug Injury Law web site:

http://www.druginjurylaw.com/NuvaRing-Safety-Issues.html

Thanks for reading Drug Injury Watch.

Tom Lamb

[Virginia]

A friend of mine, who is a non-smoker, non-drinker, 28 year-old, who was on NuvaRing for the last few years, has recently suffered a pulmonary embolism, causing her to stay 13 days in Intensive Care and another 2 weeks away from her job. Women are not yet aware of the risks caused by contraceptives and doctors fail to advise.