NuvaRing is a contraceptive vaginal ring, about 2 inches in diameter that releases a combination of estrogen and progestin over 3 weeks, followed by 1-week ring-free period. It sounds perfect for women who like the effectiveness of hormonal birth control methods, but don't want to have to remember to take a pill; unfortunately, NuvaRing comes with dangerous side effects.

NuvaRing 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 to two types of blood clot related conditions: pulmonary embolism (PE); and deep vein thrombosis (DVT). These blood conditions can cause strokes and heart attacks.

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 Events
• Pulmonary Embolism
• Death

Misty Liebert, of Missouri, says she was only on it for three weeks, when she suddenly started coughing up blood. She was rushed to the emergency room but, it took doctors several days to find out the cause. Turns out, Misty had pulmonary embolism, or blood clotting in the lungs. Read the news story.

Many women across the nation are complaining about the same side effects.

 

If you want to learn more, visit me at DrugInjuryLaw.com.

In my regular routine of checking for news updates on NuvaRing, I've noticed more and more comments being made about convenience versus risk. Where does one draw the line? There's no doubt about it, the NuvaRing is convenient. You put the ring in, forget about it for three weeks, then take it out for one week and start all over again. There's no pill to remember, no scares when you miss a pill. Simply easy. But how do you decide when easy just isn't worth it.

In the past couple years there have been more and more incidents of injuries caused by the NuvaRing, and, as a result, serious warning label changes. These risks range from deep vein thrombosis (DVT) in the extremities, pulmonary embolisms (PE) , to serious and life changing strokes. And these injuries aren't just befalling women who smoke, are overweight, or are over 35. These blood clots and strokes are affecting healthy young women.

One might reply that these are side effects that are present regardless of which birth control you use, and that is true. However, it is not as widely known that the risk for blood clots and strokes is actually higher with the NuvaRing than for regular birth control pills. The reason for this is the method of dosage. Contraceptive pills are taken each day, thus all that is required to be effective is a small amount of estrogen and progestin. However, NuvaRing is designed in such a way that it must last for 3 weeks. This means that its initial estrogen/progestin content is much higher, and the amount of medicine in your blood stream is a lot higher, too. When all is taken into account, the risk raises accordingly.

There are even multiple websites and articles popping up advising women on how to skip periods by forgoing their usual one week "break" a month from hormones. Thus far, scientists are unsure about how continuous hormone use might increase the risk for blood clots and strokes, though most suspect that increasing the body's intake of hormones like estrogen must also increase the risks that go along with this exposure.

Many doctors, most adamantly Dr. Leslie Miller, conclude that it is not unsafe to miss a period. However, they fail to make such claims about continuous hormone exposure. Whereas it may be safe to skip a period, it does not follow that continuous hormone exposure is a safe means by which to skip a period. From the organization Society for Menstrual Cycle Research:

----> "...further research on the potential health risks and long-term safety of cycle-stopping contraception is still needed."

----> "It is important to note that cycle-stopping contraceptives do not only reduce or eliminate menstrual bleeding, but also suppress the complex hormonal interplay of the menstrual cycle. The impacts of this cycle on women's health are not completely understood."

----> "Historically, nasty surprises with hormonal therapies for women (e.g...the link between oral contraceptives and blood clots, DES and various health problems) have taken many years to surface. Additionally, when any medication is evaluated for healthy women, the potential risks should be weighed more heavily than in situations when medication is considered to treat a disease."

All I am wondering here is, in our age of ease and convenience, so many things are left unevaluated. It's easy so we do it. It saves time, so we use it. Its fast, cheap, and on every corner, so we eat it. When it comes down to it, what does it take to put our health and lively-hood over convenience?

I don't have the answers, you tell me!

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 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, visit The Washington Post.

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." -Coralee

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.

If You Are Hurt By NuvaRing, Will You Be Able to Sue the Drug Company? Maybe Not.

In March 2008, I was interviewed by Mark Uehling at ClinPage.com to answer speculation about when the drug safety wars going on now with the FDA, the Supreme Court, and the pharmaceutical companies might end, if ever.

The outcome of the November 3, 2008 Supreme Court case, Wyeth v. Levine, will answer the issue of whether manufacturers of drugs should be sheltered from plaintiffs' lawsuits if the drug is approved by the FDA. If granted, this "federal preemption" would mean that most people injured by a drug would be prevented from filing a lawsuit. What do you think?

Read the article >>

Read about it on my blog, DrugInjuryWatch >>