Tuesday, May 3, 2011


Possible Side Effects and Risks

The common side effects reported by NuvaRing® users are:
  • Vaginal infections and irritation
  • Vaginal secretion
  • Headache
  • Weight gain
  • Nausea
In addition to the risks and side effects listed above, users of combination hormonal birth control methods have reported the following side effects:
  • Vomiting
  • Change in appetite
  • Abdominal cramps and bloating
  • Breast tenderness or enlargement
  • Irregular vaginal bleeding or spotting
  • Changes in menstrual cycle
  • Temporary infertility after treatment
  • Fluid retention (edema)
  • Spotty darkening of the skin, particularly on the face
  • Rash
  • Weight changes
  • Depression
  • Intolerance to contact lenses
  • Nervousness
  • Dizziness
  • Loss of scalp hair

Call your doctor right away if you get any of the symptoms listed below. They may be signs of a serious problem:

  • Sharp chest pain, coughing blood, or sudden shortness of breath (possible clot in the lung)
  • Pain in the calf (back of lower leg; possible clot in the leg)
  • Crushing chest pain or heaviness in the chest (possible heart attack)
  • Sudden severe headache or vomiting, dizziness or fainting, problems with vision or speech, weakness, or numbness in an arm or leg (possible stroke)
  • Sudden partial or complete loss of vision (possible clot in the eye)
  • Yellowing of the skin or whites of the eyes (jaundice), especially with fever, tiredness, loss of appetite, dark-colored urine, or light-colored bowel movements (possible liver problems)
  • Severe pain, swelling, or tenderness in the abdomen (gallbladder or liver problems)
  • Sudden fever (usually 102°F or more), vomiting, diarrhea, dizziness, fainting, or a sunburn-like rash on the face or body (very rarely, toxic shock syndrome)
  • Breast lumps (possible breast cancer or benign breast disease)
  • Irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than a few days
  • Urgent, frequent, burning and/or painful urination, and cannot locate the ring in the vagina (rarely, accidental placement of NuvaRing® into the urinary bladder)
  • Swelling (edema) of your fingers or ankles
  • Difficulty in sleeping, weakness, lack of energy, fatigue, or a change in mood (possible severe depression)

Few women stop using NuvaRing® because of side effects

In clinical trials involving 2500 women, only 1% to 2.5% of women discontinued using NuvaRing® because of side effects. The most frequent side effects leading to discontinuation included: device-related events, vaginal symptoms (discomfort/vaginitis/vaginal secretion), headache, mood swings, and weight gain.

Risks of NuvaRing®

• Blood clots

The hormones in NuvaRing® may cause changes in your blood clotting system which may allow your blood to clot more easily. If blood clots form in your legs, they can travel to the lungs and cause a sudden blockage of a vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or other vision problems. The risk of getting blood clots may be greater with the type of progestin in NuvaRing® than with some other progestins in certain low-dose birth control pills. It is unknown if the risk of blood clots is different with NuvaRing® use than with the use of certain birth control pills.

If you take hormonal contraceptives and need elective surgery, need to stay in bed for a prolonged illness or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor or health care provider about stopping hormonal contraceptives 3 to 4 weeks before surgery and not taking hormonal contraceptives for 2 weeks after surgery or during bed rest. You should also not take hormonal contraceptives soon after delivery of a baby. It is advisable to wait for at least 4 weeks after delivery if you are not breastfeeding. If you are breastfeeding, you should wait until you have weaned your child before using the Pill (see PRECAUTIONS, NURSING MOTHERS in the Full Product Information).

• Strokes and heart attacks

Hormonal contraceptives may increase your risk of strokes (blockage of blood flow to the brain) or heart attacks (blockage of blood flow to the heart). Any of these conditions can cause death or serious disability. Smoking greatly increases the risk of having strokes and heart attacks. Furthermore, smoking and the use of combination hormonal contraceptives, like NuvaRing®, greatly increases the chances of developing and dying of heart disease. If you use combination hormonal contraceptives, including NuvaRing®, you should not smoke.

• High blood pressure and heart disease

Combination hormonal contraceptives, including NuvaRing®, can worsen conditions like high blood pressure, diabetes, and problems with cholesterol and triglycerides.

• Cancer of the reproductive organs and breast

Breast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This small increase in the number of breast cancer diagnoses gradually disappears during the 10 years after stopping use of the Pill. It is not known whether the difference is caused by the Pill. It may be that women taking the Pill are examined more often, so that breast cancer is more likely to be detected. You should have regular breast examinations by a health care provider and examine your own breasts monthly. Tell your health care provider if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram.

Women who currently have or have had breast cancer should not use hormonal contraceptives, including NuvaRing®, because breast cancer is usually a hormone-sensitive tumor.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. There is insufficient evidence to rule out the possibility that Pills may cause such cancers.

• Gallbladder disease

Combination hormonal contraceptive users may have a higher chance of having gallbladder disease.

• Liver tumors

In rare cases, combination hormonal contraceptives, like NuvaRing®, can cause noncancerous (benign) but dangerous liver tumors. These benign liver tumors can break and cause fatal internal bleeding. In addition, it is possible that women who use combination hormonal contraceptives, like NuvaRing®, have a higher chance of getting liver cancer. However, liver cancers are extremely rare.

• Lipid metabolism and inflammation of the pancreas

In women with inherited defects of lipid metabolism, there have been reports of significant elevations of plasma triglycerides during estrogen therapy. This has led to pancreatitis in some cases.

Next: Who Should Not Use NuvaRing®? >>

Prescription NuvaRing® is a flexible vaginal ring approved for the prevention of pregnancy in women.
For additional important information, please see the FULL PRODUCT INFORMATION, INCLUDING BOXED WARNING.
  • The use of combination oral contraceptives is associated with increased risks of several serious side effects, including blood clots, stroke or heart attack. NuvaRing is not for women with a history of these conditions. The risk of getting blood clots may be greater with the type of progestin in NuvaRing than with some other progestins in certain low-dose birth control pills. It is unknown if the risk of blood clots is different with NuvaRing use than with the use of certain birth control pills
  • Cigarette smoking increases the risk of serious cardiovascular side effects when you use combination oral contraceptives. This risk increases even more if you are over age 35 and if you smoke 15 or more cigarettes a day. Women who use combination hormonal contraceptives, including NuvaRing, are strongly advised not to smoke
  • NuvaRing® is not for women with certain cancers or those who may be pregnant.
  • NuvaRing® does not protect against HIV infection and other sexually transmitted diseases
  • The most common side effects reported by NuvaRing® users are: vaginal infections and irritation, vaginal secretion, headache, weight gain, and nausea
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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