Etonogestrel/Ethinyl Estradiol Vaginal Ring
NuvaRing® is a hormonal contraceptive that works in a similar way to
the oral birth control pill and the Ortho Evra birth control patch. The
NuvaRing, however, is a flexible, soft, two-inch ring that is worn in
the vagina for three weeks and removed for one week.
the fourth week, which is NuvaRing-free, the woman will have a
menstrual period—like those using the pill or the patch. After the
ring-free week, a new NuvaRing may be inserted and the cycle begins
Patients insert the NuvaRing
while lying down, standing or squatting. They simply press the sides
together, push it gently into the vagina, and position it deep inside
where the vaginal muscles will hold it into place. NuvaRing users do
not feel the ring when it is correctly in place, and it should not be
affected by exercise or intercourse.
NuvaRing is manufactured by Organon USA (partnered with Organon in Oss,
the Netherlands). Organon is the largest of three pharmaceutical
companies owned internationally by Akzo Nobel in the Netherlands. Akzo
Nobel operates in more than 80 companies with about 66,000 employees.How hormonal contraceptives work
contraceptives release estrogen and progestin hormones into the body,
preventing the ovaries from releasing eggs and thinning the uterine
lining to prevent implantation of a fertilized egg. Additionally, these
hormones thicken cervical mucus, thus preventing sperm from entering
the uterus.History of the NuvaRing
NuvaRing was approved by the Food and Drug Administration (FDA) in
October 2001, just one month before the Ortho Evra birth control patch
was approved. The NuvaRing is the first hormonal vaginal contraceptive
ring on the market.
Studies conducted by the FDA during the approval process say that this form of birth control is 99 percent effective.
Inc.—a pharmaceutical company headquartered in West Orange, NJ, and NV
Organon, the Netherlands—developed the NuvaRing. An FDA Talk Paper (http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01107.html
references two trials including more than 2,300 women in the U.S.,
Europe, Canada and Israel. The NuvaRing was evaluated during these
trials for safety, effectiveness and acceptability among these women.How the NuvaRing works
NuvaRing releases etonogestrel (a progestin hormone) and ethinyl
estradiol (an estrogen hormone) through the vaginal wall directly into
the blood stream to prevent pregnancy.
2005 report from Organon USA said that data showed that estrogen
exposure when using the NuvaRing was “significantly lower than that
achieved with the transdermal patch and oral contraceptive.”
Further details of the report follow:
“The pharmacokinetic comparison of ethinyl estradiol (EE) released from the transdermal patch (Ortho Evra®3
), an oral contraceptive (Microgynon®4
and NuvaRing® demonstrates that estrogen exposure with NuvaRing® was
3.4 times lower than observed with the patch and 2.1 times lower than
observed with the oral contraceptive. Both differences were
statistically significant. Such a three-way comparison of different
hormonal contraceptives with different routes of administration has not
been previously reported.”Oregon Usa LawHealth risks
the risks of other hormonal contraceptives like the pill and the Ortho
Evra patch, the NuvaRing increases the possibility of blood clots,
stroke and heart attack in patients. The label also carries a bold
warning about the dangers of cigarette smoking while using this drug.
Smoking can seriously increase the risk of cardiovascular complications
among patients using hormonal contraceptives.
2005, the FDA changed the labeling for the NuvaRing, adding warnings of
bleeding irregularities, and stating that the drug product should not
be used in women who have valvular heart disease with thrombogenic
complications. The changes also included the additions of precautions
including tampon use, Toxic Shock Syndrome (TSS), drug interactions and
).Adverse effects of the NuvaRing
Many risks and side effects have been reportedly associated with the NuvaRing and other hormonal birth control.Serious side effects:
See a doctor immediately you experience any of the following symptoms!
Chest pain or breathing difficulty.
Severe headaches, weakness or numbness.
Pain in the arms or legs (especially calf or thigh).
Vision loss or flashing lights.
Severe abdominal pain.
Jaundice (yellowing of skin or eyes).
Drastic change in mood.
of these symptoms may be warnings of blood clot (thrombosis), stroke,
heart attack, pulmonary embolism or other serious medical problems. Go
to the emergency room or call your doctor immediately if you are
experiencing the above symptoms!Serious risks:
Blood clot (thrombosis)
Heart attack (myocardial infarction)
Elevated blood pressure
Hepatic adenomas (benign liver tumors)Common side effects:
Increased vaginal discharge
Upper respiratory infectionOther possible side effects:
Intolerance to contact lenses
Cramps and bloating
The NuvaRing Web site includes the following warning:
IMPORTANT SAFETY INFORMATION
does not protect against HIV infection and other sexually transmitted
diseases. The use of combination oral contraceptives is associated with
increased risks of several serious side effects, including blood clots,
which may lead to stroke or heart attack. 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; women who
use combination hormonal contraceptives are strongly advised not to
smoke. For additional important information, please see NuvaRing®
(full prescribing information)
- Pregnancy & Female Reproduction Drugs: Overview
- Blood Clots
- Heart Attack Lawsuits
- Heart Problems