Erika Langhart had traveled to 37 countries and served on the staff of a presidential nominee before even graduating college. Just before Thanksgiving 2011, her boyfriend came home to find the young law student on the floor of their apartment in extreme pain. Paramedics were already on the way, but Langhart suffered two heart attacks before they got her to the hospital and slipped into a coma. She died on Thanksgiving Day. Langhart was 24 years old.
One of the first questions the emergency room doctor asked family members was if Langhart was using birth control. When her mother, Karen, said Erika had been using NuvaRing, the doctor told her of a link between the contraceptive and pulmonary embolisms.
These deadly blood clots are among the most serious risks associated with the popular NuvaRing birth control ring. Warnings of the risks would not be added to NuvaRing’s label until almost two years after Langhart’s death.
Timeline: Rising Popularity, Increased Risks
FDA approves NuvaRing
6 percent of U.S. women who have used birth control in the previous four years report having used NuvaRing
FDA-funded study of 835,826 women finds “increased risk of VTE” among NuvaRing users
759,000 women surveyed in the U.S. report having used NuvaRing in the previous month
Study finds 6.5 times higher risk of VTE for NuvaRing compared to other hormonal birth control
Study finds increased heart attack and stroke risk
FDA approves NuvaRing label warning for VTE and other vascular risks
Convenience, Potentially Dangerous Side Effects
Despite the label warnings added in 2013 that include a risk of “thromboembolic events,” NuvaRing remains a popular contraceptive choice because it is convenient and effective.
It is inserted in the vagina once a month and only IUDs and injectable contraceptives have better rates of preventing pregnancy when used as directed. NuvaRing’s effectiveness is equal to birth control pills and patches.
NuvaRing, like the patch and pill, is a combined hormonal contraceptive (CHC) — a combination of estrogen and progestin. The use of any CHC increases the risk of a venous thromboembolism (VTE) — a blood clot that begins in a vein. There are two types of VTEs:
- Deep vein thrombosis (DVT)
DVT is a blood clot that usually forms in the leg but may form in the arms or veins in other parts of the body.
- Pulmonary embolism (PE)
PE happens when a DVT clot breaks free and travels to the lung, blocking blood flow — with potentially fatal results. These clots usually form in the thigh.
VTEs are life-threatening conditions. If you suspect you have either a DVT or a PE, you should seek immediate medical attention.
What Are the Symptoms of DVT?
DVT usually affects the lower leg or thigh, and most often occur only on one side of the body.
Symptoms of DVT include:
- Thigh or calf tenderness
- Leg pain
- Reddish discoloration
- Edema – leg swelling
- Skin is warm to the touch
- Red streaks on the leg
What Are the Symptoms of PE?
PE can be a fatal result of a blood clot in the leg breaking free and reaching the lungs.
Symptoms of PE include:
- Unexplained shortness of breath
- Fast heart rate
- Chest pain beneath the rib cage
- Rapid breathing
While smoking, obesity, and a family history of VTE can increase the risk for women using a CHC, several studies have found an association between one of the hormones in NuvaRing, etonogestrel, and a higher risk of VTE than that of birth control pills. Some studies found the risk of VTE for NuvaRing users was almost double that of women using oral contraceptives.
Studies: NuvaRing Poses Cardiovascular Risks
In October 2011, the U.S. Food and Drug Administration (FDA) released a study of more than 835,826 women that found use of NuvaRing was “associated with a significantly higher risk of VTE” compared to low-dose oral contraceptives. The authors said the finding was “new and raises concern” and called for further studies.
Another study published in May 2012, which followed more than 1.6 million Danish women from 2001 to 2010, was “compatible with the [FDA] study,” in the words of its authors. The 2012 study included data on “all Danish non-pregnant women aged 15-49” who were “free of previous thrombotic disease or cancer.”
Researchers found that “vaginal rings increased the risk of venous thrombosis 6.5 times compared with non-use of hormonal contraception.” The authors also wrote that NuvaRing “conferred a 90 percent higher risk of blood clots than oral contraceptives containing levonorgestrel.”
In June 2012, the New England Journal of Medicine published another Danish study based on 15 years of data. This study found increased risks of myocardial infarctions (heart attacks) and thrombotic strokes.
“Our data suggest a relatively high risk of thrombotic stroke with the use of a vaginal ring and possibly with the use of transdermal patches,” the researchers wrote.
In October 2013, the FDA approved new warnings for NuvaRing’s label.
- Stop using NuvaRing if a thrombotic event occur
- Use of CHCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events
- Use NuvaRing with caution in women with cardiovascular disease risk factors
By this time, court documents showed hundreds of women in the U.S., or their survivors, had suffered VTEs or other serious complications while using NuvaRing.
Other NuvaRing Complications
NuvaRing’s label lists other warnings and precautions of possible conditions women may experience.
|Toxic shock syndrome||A serious disease caused by staphylococcus bacteria involving fever, shock and problems with several organs||Confusion, diarrhea, headaches, high fever, chills, low blood pressure, muscle aches, nausea vomiting, organ failure, redness of eyes, mouth, and throat, sunburn-like rash, seizures|
|Liver disease||Liver function may be disrupted, liver tumors called hepatic adenomas may burst causing potentially fatal bleeding, and long-term use can increase risk of certain liver cancers||Jaundice, pain or mass in abdomen|
|High Blood Pressure||An increase in high blood pressure has been reported by women using CHCs. This risk increases with age. It can result in stroke, heart failure, heart attack, and kidney failure||Symptoms do not usually appear until the body is damaged from chronic high blood pressure|
|Headaches||Women who experience new, more frequent, severe headaches should consult their doctor while using NuvaRing||New, recurring, persistent, or severe headaches|
|Uterine bleeding||Unscheduled bleeding may occur with users of CHCs in the first three months of use. If this persists beyond three months while using NuvaRing, you should talk to your doctor||Unscheduled bleeding and spotting|
|Amenorrhea||Lack of a scheduled period while using NuvaRing — this may indicate pregnancy||Failure to experience a period on schedule|
|Oligomenorrhea||Infrequent periods||Periods occur more than 35 days apart|
NuvaRing: Symptoms You Should Contact Your Doctor About
The National Institutes of Health recommends you talk to your doctor immediately if you experience any of these symptoms while using NuvaRing.
Symptoms are warning signs of the following conditions:
VTE: DVT or PE
- Pain in back of lower leg
- Sharp, sudden, or crushing chest pain
- Heaviness in chest
- Coughing up blood
- Swelling of the hands, feet, ankles, or lower legs
Stroke or heart attack
- Sudden shortness of breath
- Sudden severe headache, vomiting, dizziness or fainting
- Sudden problems with speech
- Weakness or numbness of an arm or leg
- Sudden loss of vision or other changes in vision
- Bulging eyes
Liver or gallbladder disorder
- Yellowing of the skin or eyes
- Pain, tenderness, or swelling of the abdomen
- Stomach pain that worsens after eating
- Trouble sleeping
- Loss of energy
- Mood swings
Toxic shock syndrome
- Sunburn-like rash — skin peeling occurs one or two weeks after the rash, particularly on the palms of the hand or bottom of feet
- Painful, difficult, or frequent urination
Who Should Not Use NuvaRing
Women with certain conditions should not use NuvaRing because it may worsen or lead to a serious complication.
You should advise your doctor if you have or meet any of these conditions:
- Over the age of 35 and smoke or have migraine headaches
- High risk of VTE
- Coronary artery disease
- Increased tendency for blood clotting
- Diabetes with vascular disease
- Certain severe headaches
- Thrombogenic valvular or rhythm diseases such as atrial fibrillation
- Liver tumors or liver disease
- Breast cancer or other cancers sensitive to estrogen or progestin, currently or in the past
- Hypersensitivity to NuvaRing components
- Conditions affecting blood flow to the brain