The NuvaRing birth control ring is popular because it is convenient and effective. Unfortunately, a number of women who used it suffered from dangerous side effects.
It is the world's first and only vaginal birth control ring and reached $623 million in international sales in 2011. NuvaRing is a flexible ring about 2 inches in diameter that a woman inserts into the vagina once a month to prevent pregnancy. NuvaRing was originally manufactured in the Netherlands by Organon, which was later acquired by Schering-Plough – now known as Merck. Since its introduction in 2001, NuvaRing has been prescribed more than 5.5 million times. Its popularity is based on its convenience — it is just as effective as birth control pills, and women don't have to worry about remembering to take a pill every day.
The combination of hormones released by NuvaRing prevents ovulation, changes cervical mucus (making it difficult for sperm to enter), and reduces the likelihood of implantation. NuvaRing does not prevent menstrual cycles or protect against sexually transmitted diseases. If the ring comes out, which is rare, it can be rinsed and reinserted within three hours. It is not known to disrupt sexual intercourse.
Although the pill remains the most commonly used contraceptive, NuvaRing has become a popular alternative for women who prefer not having to take a pill every day. After it is inserted, it remains in place for three weeks and then is taken out, at which point a woman should have a regular period. A week after it is taken out, a new ring is inserted. It releases a continuous daily dose of 0.120 mg of etonogestrel (progestin) and 0.015 mg of ethinyl estradiol (estrogen) and is 99 percent effective at preventing pregnancy.
In a randomized study of satisfaction level with contraceptives, 201 women were randomly given NuvaRing or birth control pills and followed for three months. At the end of the study period, the women were interviewed, and 87 percent of women who used the ring reported high satisfaction. In fact, the women who used the ring were eight times more likely to choose the ring over the pill.
Despite NuvaRing's effectiveness and ease of use, it also comes with the risk of serious side effects, including life-threatening blood clots, heart attack and stroke. More than 1,500 people have filed federal lawsuits against Merck, the product's manufacturer, claiming the company created a defective product, failed to adequately test the product, engaged in deceptive marketing and failed to properly alert consumers to the dangers associated with NuvaRing.
In February 2014, Merck reportedly agreed to pay $100 million to settle more than 1,700 NuvaRing lawsuits. That amounts to about $58,000 for each woman.
Risk of Blood Clots and Heart Problems with NuvaRing
The most serious side effects associated with NuvaRing are the increased risk of blood clots, heart attack and stroke. NuvaRing may increase the risk of these conditions because it contains etonogestrel, an active metabolite of desogestrel in the progestin hormone family. This hormone is also used in birth control pills. Desogestrel is considered a third-generation progestin, while some birth control pills use fourth-generation progestins.
Third- and fourth-generation progestins have been linked to increased risk of deep vein thrombosis (DVT) (blood clots) and pulmonary embolism (PE) (blood clots in the lungs). In addition, the risk of heart attack and stroke is also increased. These complications can lead to death. Other popular contraceptives like Orthra Evra and Yaz/Yasmin also have been associated with blood clot risks. Yaz/Yasmin, which uses a fourth-generation progestin, has been associated with a 74 percent increase of developing blood clots.
NuvaRing's labeling information includes warnings of risks of venous, arterial and pulmonary embolisms. Arterial embolisms form in the arteries and can lead to myocardial infarction (heart attack). Venous thromboembolisms (VTEs) are blood clots that form in the veins and may start in the legs, arms or groin, then break loose and travel to the lungs. When the clot is in the lungs, it is called a pulmonary embolism, and can block the airways and become fatal. NuvaRing releases low daily doses of hormones, but unlike the oral third-generation contraceptives, the hormones from NuvaRing are directly absorbed by the body. About half of the hormones released by oral contraceptives disappear in the digestive tract. There has not yet been a definitive study to show how much more harmful NuvaRing's level of absorption may be. However, the mounting reports of adverse events suggest that NuvaRing may pose a greater threat than other combined hormone contraceptives.
Warning Signs of a Possible Blood Clot
Blood clots pose a serious threat to health and should be treated immediately. Knowing the signs can alert a woman to seek treatment before problems worsen.
|Symptoms of a blood clot include:|
|Swelling of arm or leg||A warm spot on the leg|
|Skin redness||Soreness or pain in the arm or leg|
|Signs that the clot may have moved to the lungs include:|
|Chest pain||Difficulty breathing|
|Fast heartbeat||Fainting spells|
|Cough, with or without blood||Mild fever|
Other Side Effects of NuvaRing
While most women do not complain of discomfort while using NuvaRing, side effects can include vaginal infection and irritation, headache, weight gain, vaginal secretion and nausea. Since NuvaRing is a part of a group of birth control medications known as combined hormonal contraceptives (CHCs), it shares several side effects with other CHCs, which typically include both estrogen and progestin.
|Combined hormonal contraceptives can:|
|Worsen conditions like high blood pressure, diabetes and problems with cholesterol and triglycerides|
|Increase the risk of breast cancer (Women with a history of breast cancer should not use CHCs.)|
|Possibly increase the risk of cervical cancer|
|Increase the risk of gallbladder disease|
|Cause noncancerous (benign) liver tumors to develop, which can cause fatal internal bleeding|
|Symptoms that may signify serious problems include:Intense headache, vomiting, light headedness, problems with vision or speech and numbness of arms or legs (possible stroke)|
|Yellowing of skin or eyes (jaundice) combined with fever, tiredness, dark-colored urine (liver problems)|
|Breast lumps (breast cancer or benign breast disease)|
|Severe pain or swelling in abdomen (gallbladder or liver problem)|
|Fever over 102 with vomiting, diarrhea, fainting, dizziness, fainting, and rash (toxic shock syndrome)|
|Irregular vaginal bleeding|
|Frequent, painful need to urinate combined with losing vaginal ring (occasionally the ring is placed in the urinary bladder)|
|Difficulty sleeping, weakness, change in mood (severe depression)|
FDA Action and Clinical Studies
In February 2007, Public Citizen sent a petition representing more than 100,000 consumers to the Food and Drug Administration (FDA) requesting that it ban third-generation oral contraceptives due to the approximate doubled risk of venous thrombosis, which can cause fatal pulmonary embolisms. The petition was unsuccessful in getting the FDA to ban third-generation contraceptives, but it did bring to light the dangers of this type of contraceptives.
In October 2011, the FDA released a drug safety report with results from a study of more than 800,000 women that found that users of NuvaRing have an increased risk of venous thromboembolism (VTE) compared with users of low-dose oral contraceptives. Another study conducted from 2001 to 2010 revealed that "women who use transdermal patches and vaginal rings for contraception have a 7.9 and 6.5 times the increased risk of venous thrombosis compared with non-users of hormonal contraception of the same age."
In this same study, researchers found that the hormone in NuvaRing conferred a 90 percent higher risk of blood clots than oral contraceptives containing levonorgestrel. In fact, the risk was comparable to some of the most high-risk combined oral contraceptives like Yaz, Yasmin and Ocella.
With the ever-increasing number of adverse events, researchers continue to study this birth control device. In June 2012, the New England Journal of Medicine published a Danish study based on 15 years of data. The study reported that additional increased risks of hormone contraceptives include myocardial infarctions (heart attacks) and thrombotic strokes.
A clinical trial known as the Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC) has been collecting data from September 2007 to June 2012. The study results are yet to be published. TASC is supported by the German Federal Institute for Drugs and Medical Devices, and may provide more statistical evidence concerning the risks of heart attacks and strokes.
The number of lawsuits against Merck has been steadily rising. After using NuvaRing and suffering from negative side effects or losing loved ones, claimants have filed lawsuits against the drug's manufacturer. In 2008, federal cases were consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Missouri.
According to Bloomberg, Merck settled nearly all federal and state lawsuits in early 2014 for $100 million.