NuvaRing: News and Information

NuvaRing is a contraceptive vaginal ring manufactured by Organon USA, Inc. which was approved for sale on the U.S. market in October 2001. Since that time there have been numerous reports of serious side effects associated with NuvaRing involving blood clots, some of which have resulted in death. Specifically, NuvaRing has been linked several serious types of blood clot related conditions: pulmonary embolism (PE), deep vein thrombosis (DVT), strokes, and heart attacks. These conditions can, and sometimes do, lead to death.

NuvaRing is a combined contraceptive vaginal ring, with ethinyl estradiol (EE) being the estrogen part and etonogestrel being the progestin part. NuvaRing releases 15 micrograms of ethinyl estradiol and 120 micrograms etonogestrel per day.

On the positive side, medical journal articles have reported on studies which show that NuvaRing has the same contraceptive efficacy as low-estrogen-dose birth control pills.

On the negative side, however, NuvaRing has a relatively high dose of etonogestrel, a metabolite of desogestrel, which has been recognized as a dangerous progestin.

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.

NuvaRing has been associated with other adverse side effects such as:

• Stroke


• Heart Attack


• Deep Vein Thrombosis


• Myocardial Infarction


• Cerebrovascular Accidents


• Pulmonary Embolism


• Death

For more information on NuvaRing you may also wish to visit my law firm's web site, www.DrugInjuryLaw.com. In the alternative, you may also submit a confidential free case evaluation.



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In 1960 the FDA approved the first ever hormonal contraceptive, the birth control pill. Engendered by Margaret Sanger, founder of Planned Parenthood, strongly believed that only in ideal circumstances should a man and woman conceive. The pill was her idea to help families wait and time conception for that perfect moment. Although Sanger's motives have been considered less than ethical, and often downright racist, her vision did lead to the sexual empowerment of women the world over.

Since that time there have been many "advancements". We now have the patch, the ring, IUDs, birth control pills which help with acne and premenstrual disorders, and pills which even allow a woman to skip her period for months or even years. What the pill can do, and allows women to do, has come a long way. But how far have advancements in safety come?

Only two years after Enovid, the first contraceptive pill to receive FDA approval, hit the markets, their were numerous reports of safety issues. Most were related to blood clotting:

"There were reports of blood clots, strokes --and possible links to cancer. As early as 1962, the manufacturer of the birth control pill Enovid, G.D. Searle and Company, received reports of 132 cases of blood clots in Pill users. Eleven of the cases resulted in death. Searle maintained that there was no conclusive proof that the Pill caused those deaths, and the FDA assured doctors the drug was safe." (PBS.org)

The incidents only grew. Now, with the advent of more "convenient" birth control choices such as Ortho Evra and NuvaRing, and birth control pills that "go beyond" such as antiandrogenic pills like YAZ, Yasmin, and Ocella, the safety issues associated with these new combination contracptives are reaching the mainstream media, and therefore, the public.

Interestingly enough, study after study has shown that the older hormonal contraceptives containing ethinyl estradiol and levonorgestrel, are the safest. The controversy now remains: why are these new progestins, such as drospirenone (in YAZ, Yasmin, and Ocella) and etonogestrel (found in NuvaRing), which appear to have more risk for thromboembolisms, allowed to remain on the market?

If there is a safe effective hormonal contraceptive available, why does the FDA continue to allow these new formulations? The ability to prevent pregnancy is not changing with these contraceptives, but the safety aspect is. Hormonal contraceptives appear to be increasingly dangerous. Where are the safety innovations? Rather than pouring money into research which might make hormonal contraceptives safer, pharmaceutical companies want products which are more convenient and have more uses, making them more money.

Earlier this year, I wrote a summary of a paper entitled "The Bitterest Pill" which examines these very issues. Perhaps it is worth taking another look in light of hormonal contraceptives' upcoming 50th birthday in 2010.

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Visit the Drug Injury Watch Focus Page on NuvaRing. There you will find a compilation featuring each of the posts from Drug Injury Watch written on this convenient but questionable birth control method. These posts are packed full of information ranging from safety issues to current litigation in NuvaRing lawsuits.

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NuvaRing Now Available In India And Apparently With None Of The Side Effects
November 20, 2009

Earlier this week Nuvaring was launched to be available to women in India. NuvaRing stands out from other birth control methods because, rather than having to remember to take a pill each day, this flexible vaginal ring is inserted only once a month. But in India the NuvaRing stands out even more.

"Around 20 percent women use contraceptives in India. The ring will be good as does not have any side effects and will not cause obstruction in any other routine activity [emphasis mine]," said K.G. Anathakrishnan, the managing director of Organon (India) as reported in one of India's national newspapers The Times of India.

No side effects?! None?? Wow, is India getting a different, better, safer NuvaRing than the one that we have come to know so well?

From the US NuvaRing package insert:

What are the possible risks and side effects of NuvaRing®?

• Blood clots
  
• Strokes and heart attacks
  
• High blood pressure and heart disease
  
• Cancer of the reproductive organs and breast
  
• Gallbladder disease
  
• Liver tumors
  
• Lipid metabolism and inflammation of the pancreas
  

The common side effects reported by NuvaRing® users are:

• vaginal infections and irritation
  
• vaginal secretion
  
• headache
  
• weight gain
  
• nausea
  

Hopefully someday they will introduce the new side-effect-free NuvaRing here in the US. Until then, I urge you to discuss the possible risks associated with any birth control method you are considering with your doctor.

Mother Jones takes a long look at NuvaRing in the article, "Is NuvaRing Dangerous?"
May 15, 2009

"Is NuvaRing Dangerous?" begins with a horrifying story of a young wife and mother of two who died due to a blood clot in her lungs believed to be caused by NuvaRing. She was, "perfectly healthy. She didn't smoke, nor did she have any history of clots."

Many people are already aware of the risks involved in hormonal contraception. It is true, any form of contraception which is hormone-based carries a risk of blood clots and strokes. However, birth control options which employ third-generation hormones, such as NuvaRing, YAZ, and Yasmin, carry higher risks. From the Public Citizen Petition to the FDA,

"...three independent studies published in December 1995 all concluded third generation oral contraceptives had about twice the risk of venous thrombosis when compared to second generation oral contraceptives. Numerous similar studies have found generally the same increased risk with the most common estimate of this risk being 1.5 to 2.4 -fold higher compared to second generation oral contraceptives. The difference in venous thrombosis risk between second and third generation OCs is even higher among women who use oral contraceptives for the first time."

These studies were all done on contraceptive pills, something that highlights another difference in pills versus the NuvaRing: how the hormones are absorbed into the body. "...[W]hile birth control pills lose up to half their hormones in the digestive tract, the ring's dose is absorbed directly into the blood. It's package insert says there are no data on whether this route makes NuvaRing any riskier than taking pills..." Why is there no data? "Organon never studied the question before it marketed the ring. Nor did the FDA demand it- the agency based its approval largely on studies involving pills." (from MJ)

Let's get this straight:

1) Third generation contraceptives carry a higher risk of blood clots.
2) Third generation contraceptive pills carry two times the risk of second generation contraceptives.
3) Pills lose half of their hormones in the digestive tract.
4) NuvaRing's hormones are absorbed directly into the blood stream.

So, not only does NuvaRing carry a higher risk based on being a third generation contraceptive, but its hormones are absorbed directly into the blood stream.

The article points out a relevant and poignant comparison. In regards to the Ortho Evra patch fiasco, "The company [Johnson & Johnson] had previously claimed, as Schering-Plough now does, that its product delivered a more constant, low dose of hormones, causing fewer side effects." Yet, "from 2002 through 2006, at least 40 women died using its weekly Ortho Evra patch, most from blood clots. In 2006, the FDA ordered J&J to mark its packaging with a 'black box' warning which seriously hurt sales." (Emphasis mine)

Poor J&J. Will Schering-Plough suffer the same fate?

--> Read the Mother Jones article yourself, here.
--> The Public Citizen Petition to the FDA to Ban Third Generation Oral Contraceptives can be found here.
--> For more information on Ortho Evra, visit my other Squidoo Lens, here.

How Does NuvaRing Affect Your Heart? Who Knows?
January 26, 2009

A new State-Of-The-Art Paper in the January 20, 2009 issue of the Journal of the American College of Cardiology brings to light how little we know about how hormonal contraception, such as the NuvaRing, affects women's bodies, especially their hearts.

The risks of deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke are now really starting to become public knowledge. Many know the typical warnings about increased risk for smokers, women over the age of 35, and the obese. However, it appears that no one knows how hormonal contraception might affect the heart.

So, big deal, you might think, we can't be bogged down with knowing how everything we do affects each part of us. Perhaps this is an appropriate attitude regarding certain things, yet hormonal contraceptives are used by "over 80% of U.S. women at some point in their lifetimes." That is too large a population to justify overlooking such a vital system in the human body.

The study states:

"There are no cardiovascular data available for the newest generation contraceptive hormone formulations, including the progestins that lower blood pressure and body weight, as well as the nonoral routes (transdermal and vaginal)...specific study is needed. Current guide-lines indicate that, as with all medication, contraceptive hormones should be selected and initiated by weighing risks and benefits for the individual patient."

And that is just the trouble. How can women truly make an informed decision about hormonal birth control if the experts haven't even attempted to do the appropriate research?

Another thing that makes this type of research all the more crucial is hormonal contraception options like the NuvaRing are being used in ways not previously considered or anticipated. For one thing, women are using birth control for many years. As C. Noel Bairey Merz, co-author of the JACC study, put it, "Long-term constant use starting as teenagers and ending with menopause was not anticipated." Thus the long-term effects on the heart may be significant where they may have been less disruptive in short-term use.

The other unexpected use of NuvaRing and other hormonal contraceptives is for skipping periods, or suppressing menstruation. Many women now use their birth control regularly in order to not have their period at all. Whether this practice is safe is far from conclusive.

Merz also says, "There are other gender politics reasons that may or may not be contributing. I have said that if this was a male contraceptive, we would know much more." This is one idea behind a powerful paper, The Bitterest Pill, which seeks to show how time and time again pharmaceutical products designed exclusively for women are found, often much too late, to have fatal risks and consequences of use. Incomplete, hidden, and sugar-coated research reports from the pharmaceutical companies attempting to get their newest products on the market are too common to ignore.

Hopefully, following the release of this JACC study, researchers will be motivated to delve more deeply into the cardiovascular effects of these high-use contraceptive methods.

Read the abstract of the JACC study here, or for a Washington Post article covering the study, vi

Another Disheartening Story Illustrates, Yet Again, The Dangers of NuvaRing
December 10, 2008

"I am currently in Roseburg, Oregon, where I hosted my sister-in-law's baby shower yesterday. One guest was missing - Christina Heyniger Howington. While I have known Christina since we went to elementary school it had been quite awhile since I had seen her. However, my brother and his wife were especially close with her and her husband. She and her husband, Heath and daughter, Alyssa (13) spent Thanksgiving with my family in Sunriver last week. She had a wonderful time and was thrilled that Christmas was near. All seemed perfect in her world. She was full of life, happy, energetic, and loved her husband of 17 years and their daughter. She began using NuvaRing 2 1/2 months ago and started having headaches. They were not severe so she didn't pay too much attention. On Thursday morning, she woke up with a severe headache and began vomiting. She also became lethargic and wanted to go back to sleep. Her husband rushed her to the ER where she had a CT Scan. The first diagnosis was an aneurysm. She was helicoptered to OHSU in Portland and the diagnosis was changed to a blood clot. Once in surgery, surgeons were alarmed to find multiple blood clots throughout her brain. They tried to get to all of them and planned to do another CT Scan the following day to be sure all clots had been addressed. Christina's brain began swelling and her condition became grave. She was placed into a medically induced coma to address the brain swelling and was put on life support. By Friday, her condition worsened and her brain began shutting down. She was taken off life support in a last attempt to address her brain swelling, but efforts were halted as it was determined that her brain had no further activity. Christina lost her life but became a hero as she was an organ donor. Her lungs are already in transport to California where they will save someone's life. Blood clots, however, have been found in other organs such as her liver. Doctors are VERY suspicious that this tragedy was the result of NuvaRing birth control. They said they have had "hundreds" of cases where women are showing up with blood clots after using this contraceptive. It is my goal to honor her life by using her story to save even one other person from this terrible fate. Please pass this information along. It's the last effort we can do to honor a truly amazing woman.

Thank you for reading this."

From Adult Health

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What Are They?

Pulmonary embolism, commonly referred to in the medical community as PE, is a highly dangerous, life threatening condition.

From WebMD:
"Pulmonary embolism is the sudden blockage of a major blood vessel (artery) in the lung, usually by a blood clot. In most cases, the clots are small and are not deadly, but they can damage the lung. But if the clot is large and stops blood flow to the lung, it can be deadly. Quick treatment could save your life or reduce the risk of future problems."

Many times a PE is associated with a deep vein thrombosis (DVT), a blood clot which forms in a vein of the deep venous system. This type of blood clot can occur anywhere in the body, but they usually happen in extremities, like the leg. According to WebMD, "Among patients with DVT, pulmonary embolism will occur in 30%." This occurs because the blood clot makes its way to the lung, where very serious damage can occur.

What Are The Symptoms?

Often there are no symptoms of DVT. In fact, WebMD reports that over half of DVT cases showed no signs. However, if you do experience any of the symptoms listed below, seek medical care immediately. A DVT can quickly become a life threatening pulmonary embolism.

• Deep Vein Thrombosis
  
  
  
  • Swelling in one or both legs
    
  • Pain or tenderness in one or both legs, which may occur only while standing or walking
    
  • Warmth in the skin of the affected leg
    
  • Red or discolored skin in the affected leg
    
  • Visible surface veins
    
  • Leg fatigue
    

Although DVTs are most often the precursor to PE, don't expect a gradual onset beginning with the symptoms listed above. A pulmonary embolism can come on quickly and without warning. For that reason WebMD says that if you think you may have pulmonary embolism, call your doctor or go to the emergency room at the nearest hospital. Watchful waiting is not appropriate for pulmonary embolism.

• Pulmonary Embolism
  
  
  
  • Shortness of breath that may occur suddenly.
    
  • Sudden, sharp chest pain that may become worse with deep breathing or coughing.
    
  • Rapid heart rate.
    
  • Rapid breathing.
    
  • Sweating.
    
  • Anxiety.
    
  • Coughing up blood or pink, foamy mucus.
    
  • Fainting.
    
  • Heart palpitations.
    
  • Signs of shock.
    

Treatment and Recovery

Normally once the PE or DVT (or both) has been diagnosed, the first step is to dissolve the blood clot. From WebMD:

"If symptoms are severe and life-threatening, immediate and sometimes aggressive treatment is needed. Aggressive treatment may include thrombolytic medicines, which can dissolve a blood clot quickly but also increase the risk of severe bleeding. Another option for life-threatening, large pulmonary embolism is surgical removal of the clot, called an embolectomy. This surgery is only available at a few large hospitals."

The next step is to prevent future clotting. This involves anticoagulation medication which must be taken for several months. For an unfortunate few, it must be taken forever. All hormone therapy must be stopped (this includes any hormonal birth control methods) and if pregnancy occurs, a series a regular shots must be given to prevent clot formation.

Recovery

Recovering from pulmonary embolism can be a long and painful process. An excellent and informative source for recovery information from someone who has experienced, and recovered from, a PE has a great website over on HubPages.com. It is called Recovering From A Pulmonary Embolism.

Another avenue to connect with others and learn about the recovery process is through support groups. DailyStrength.org has a pulmonary embolism support group geared to open the lines of communication for PE sufferers everywhere.

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Shawn's Comment from August 5, 2009:
Hi - My wife has been on or should I say was on Nuvaring until today. about 2 weeks ago, she started to have chest pain and shortness of breath. Her EKG and Nuclear Stress tests show a blocked left branch and a blocked vessel and the doctors could not figure out why. She had a normal EKG as part of her physical 7 months ago. She was going to see what had changed in her and came up on some material on Nuvaring and put and 2 and 2 together. She is now off of this deadly contraceptive and in 3 weeks if her condition does not improve, she will need to have a procedure to have a stent put in. I am scared for her and I am not sure if her heart will ever be the same.

Thank you for your comment, Shawn. I appreciate you sharing your story and I truly hope that your wife recovers quickly and fully.

I am in no way qualified to provide any sort of medical advice, and only your doctors are in a position to explain what happened to your wife.

That being said, your comment brings to mind an important point. We have devoted a lot of information on this web page to blood clots which can lead to pulmonary embolism, deep vein thrombosis, or both. However, blood clots can also lead to heart attacks.

In the same way that a blood clot can form in the deep vein system and has the potential to move into the lungs, blood clots can also form or move into the heart. A clot in the heart blocks blood flow causing the tissue to die and electrical rhythms to become irregular. If blood flow is not restored quickly, the result is serious damage or even death.

A heart attack is a serious medical emergency. The National Heart Blood and Lung Institute states that treatment for a heart attack is most effective if started within one hour of the first symptoms. From the National Heart Blood and Lung Institute:

• The most common heart attack signs and symptoms are:
  
  
  
  • Chest discomfort or pain-uncomfortable pressure, squeezing, fullness, or pain in the center of the chest that can be mild or strong. This discomfort or pain lasts more than a few minutes or goes away and comes back.
    
  • Upper body discomfort in one or both arms, the back, neck, jaw, or stomach.
    
  • Shortness of breath may occur with or before chest discomfort.
    
  • Other signs include nausea (feeling sick to your stomach), vomiting, lightheadedness or fainting, or breaking out in a cold sweat.
    
  
  
• If you think you or someone you know may be having a heart attack:
  
  
  
  • Call 9-1-1 within a few minutes-5 at the most-of the start of symptoms.
    
  • If your symptoms stop completely in less than 5 minutes, still call your doctor.
    
  • Only take an ambulance to the hospital. Going in a private car can delay treatment.
    
  • Take a nitroglycerin pill if your doctor has prescribed this type of medicine
    

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NuvaRing Plaintiffs Required to Submit Complete Psychiatric History on Plaintiff Fact Sheet
November 24, 2008

Reportedly, Judge Rodney Sipple, the judge overseeing the NuvaRing MDL cases, decided in favor of the Plaintiff Fact Sheet pushed by Organon, the defendant and manufacturer of the NuvaRing. The defendant's Plaintiff Fact Sheets requires the complete psychiatric history of anyone filing a case against Organon. Surprisingly, this fact sheet even applies to plaintiffs who are not claiming any psychiatric injury as a result of their use of NuvaRing.

The counsel for the plaintiffs argued that it was unfair and unnecessary for those who were not claiming any psychological injury related to the NuvaRing to be forced to disclose their entire psychiatric history. They felt that this requirement should only pertain to plaintiffs claiming depression or emotional distress. Even those only citing mild emotional upheaval as a result of NuvaRing should not have to disclose a complete psychiatric history, they said.

However, Judge Sipple did not agree with the plaintiff's counsel. Organon's counsel won the day, and now each and every plaintiff will be forced to include psychiatric information on the Plaintiff Fact Sheet, whether it applies to them or not.

NuvaRing Manufacturers Push Preemption On MDL Cases
November 11, 2008

As a means to escape the wrath of over 150 cases which claim injuries caused by Nuvaring, the NuvaRing manufacturer, Organon, is attempting to have the multi-district litigation (or MDL) cases preempted before they have a chance to be heard.

On November 3, 2008, the Supreme Court case Wyeth v. Levine was heard, in part, to decide such preemption issues for all pharmaceutical companies in the future. Organon, in this instance, claims that because the FDA has already approved the NuvaRing and its warning labels, plaintiffs should have no right to hold them responsible for any injuries incurred.

In essence they are saying, Hey...once it's on the shelf, it's out of our hands.

Reportedly, the judge has deferred any decision until more is known about the outcome of the Wyeth v. Levine Supreme Court Case.

For more information try...
This article on NuvaRing multi-district litigation, or go here for federal preemption.

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