NuvaRing Side Effects
NuvaRing is a popular combination hormone contraceptive (CHC) like birth control pills and patches. Common side effects include headaches and inflammation of the vagina. The U.S. Food and Drug Administration requires the birth control ring to carry the agency’s most serious warning — a black box warning — about cigarette smoking and serious cardiovascular events.
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 she 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 birth control ring. Warnings of the risks would not be added to the contraceptive’s label until almost two years after Langhart’s death.
Blood clots like the one Langhart suffered are rare, according to the birth control’s packaging insert. In a large study called the Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC), researchers followed women for 24 to 48 months and the incidence of blood clots — or venous thromboembolisms (VTE) — was 8.3 in 10,000. For new users, the risk was slightly higher at 11.4 in 10,000.
In clinical trials of 2,501 women, more common side effects were minor, such as vaginitis and headaches. Vaginitis (inflammation of the vagina) occurred in about 13.8 percent of the women and headaches occurred in 11.2 percent of women.
Common Side Effects and Precautions
NuvaRing’s label warns of possible side effects women may experience. According to the medication label, the most common side effects in clinical trials were: vaginitis, headache, mood swings, nausea/vomiting, vaginal discharge, weight gain, abdominal pain, acne and decreased sex drive. These occurred in 2 percent or more of women in clinical trials of 2,501 women.
About 13 percent of the women dropped out of clinical trials for adverse events. The most common reasons were device-related events (2.7 percent), mood changes (1.7 percent), headaches (1.5 percent) and vaginal symptoms (1.2 percent).
The insert also contains general precautions for women and their doctors to consider when using the contraceptive.
|Toxic shock syndrome||Users have reported TSS, though cases are very rare. Some of the women were also using tampons.|
|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.|
|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.|
|Headaches||Women who experience new, more frequent, severe headaches should consult their doctor while using the contraceptive.|
|Uterine bleeding||Unscheduled bleeding may occur with users of CHCs in the first three months of use. If this persists beyond three months of use, you should talk to your doctor.|
|Amenorrhea or Oligomenorrhea||Infrequent periods or lack of a scheduled period while using the vaginal ring may indicate pregnancy.|
Studies: NuvaRing Increases Risk of Blood Clots
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.
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 the blood clots for NuvaRing users was almost double that of women using the pill.
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,” its authors said. The study published in the BMJ 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.”
“Vaginal rings increased the risk of venous thrombosis 6.5 times compared with non-use of hormonal contraception.”
In June 2012, the New England Journal of Medicine published another Danish study based on 15 years of data. This study found a risk of myocardial infarctions (heart attacks) and thrombotic strokes with hormonal contraception.
“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.
FDA Warning and Contraindications
In October 2013, the FDA approved new warnings for NuvaRing’s label. By this time, court documents showed hundreds of women in the U.S. had filed lawsuits after suffering VTEs or other serious complications while using the birth control.
- Use of combination hormonal contraceptives (CHC) in combination with smoking also increases the risk of serious cardiovascular events especially in women with other risk factors for these events
- The risk increases as women age, especially in women over 35
- The risk also increases with number of cigarettes smoked
Who Should Not Use NuvaRing?
Women with certain medical conditions or other lifestyle factors should not use NuvaRing.
- Smoke and are over the age of 35
- Have a high risk of arterial or venous thrombotic diseases
- Have liver tumors or liver disease
- Have undiagnosed abnormal uterine bleeding
- Are pregnant
- Have or have had breast cancer or other cancers sensitive to estrogen or progestin
- Have a hypersensitivity to any NuvaRing component
Please seek the advice of a medical professional before making health care decisions.