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About Plan B
What is Plan B?
Plan B is the first progestin-only
emergency contraceptive to be approved by the United States
Food and Drug Administration (FDA). Although oral
contraceptive pills containing progestin have been in use
for routine contraception for many years, Plan B contains
the first progestin-only tablet specifically developed for
postcoital contraception. Plan B is safe for most women and
is highly effective. Each Plan B packet includes a
single course of treatment and consists of two tablets, each
containing 0.75 mg levonorgestrel, a totally synthetic
progestogen. The first tablet should be taken as soon as
possible within 72 hours (3 days) of unprotected
intercourse. The second tablet must be taken 12 hours later.
Safe, effective, and accessible emergency contraception is
one of the most important tools for reducing the
unacceptably high number of unintended pregnancies.
According to the Alan Guttmacher Institute, there are over 3
million unintended pregnancies each year.1 Half of these end
in abortion. By reducing the risk of pregnancy after
unprotected intercourse, Plan B can substantially reduce the
incidence of unintended pregnancies and the corresponding
need for abortion.1-5
How is Plan B different
from other emergency contraceptive regimens?
Results from two randomized, comparative
studies conducted by the World Health Organization (WHO)
indicate that the new levonorgestrel-only regimen is highly
effective and much better tolerated than the Yuzpe regimen
(a 25-year old emergency contraception regimen which
combines ethinyl estradiol plus norgestrel or levonorgestrel).
The incidence of nausea in women taking Plan B was reduced
from 50.5 percent to 23.1 percent, and the incidence of
vomiting was reduced from 18.8 percent to 5.6 percent. The
studies involved 2,832 women at 22 study centers in 15
countries.
When is Plan B
appropriate?
Plan B provides an important safety net
for women whose regular contraceptive method may have
failed, or for women who may have had intercourse without
contraception. When unprotected intercourse has occurred,
Plan B is second-chance contraception. Plan B is not a
substitute for correct use of regular contraceptives. It is
less effective and provides no protection from HIV or
sexually transmitted diseases. In emergency situations,
however, Plan B can play an important role as a back-up for
other methods.
How does Plan B work?
The exact mechanism of action of Plan B
is unknown. Plan B is believed to act as an emergency
contraceptive principally by delaying ovulation or
preventing fertilization. In addition, it may inhibit
implantation by altering the endometrium.8 Once implantation
has occurred and pregnancy is established, Plan B cannot
cause an abortion.
How effective is Plan B?
Plan B reduces the average risk of
pregnancy among users from about 8 percent to about 1
percent. In other words, when used correctly, it reduces the
risk of pregnancy by 89 percent after a single act of
unprotected sex. Effectiveness declines as the
interval between intercourse and the start of treatment
increases. In the first 24 hours after intercourse, Plan B
can prevent 95 percent of expected pregnancies.6 Treatment,
therefore, should not be delayed.
How safe is Plan B?
No serious complications have been
associated with Plan B. Used as directed, Plan B is safe for
most women. Plan B is contraindicated in case of suspected
pregnancy, undiagnosed abnormal genital bleeding, or
hypersensitivity to any component of the product.
Do women who use Plan B experience side effects?
Some women experience one or more side
effects after taking Plan B. Approximately 23.1 percent of
women taking Plan B experience nausea (compared to 50.5
percent with the Yuzpe regimen), and 5.6 percent vomit
(compared to 18.8 percent).6 Other common side effects
include lower abdominal pain, fatigue, headache, dizziness,
breast tenderness and menstrual changes (see Table 1). About
58 percent of users will have their next menses on time or a
few days early or late.
Table 1: Adverse
Events
M O S T C
O M M O N A D V E R S E E V E N
T S I N C I D E N C E
Nausea 23.1
Abdominal pain 17.6
Fatigue 16.9
Headache 16.8
Heavier menstrual bleeding 13.8
Lighter menstrual bleeding 12.5
Dizziness 11.2
Breast tenderness 10.8
Other complaints 9.7
Vomiting 5.6
Diarrhea 5.0
If Plan B fails, is there a risk to the fetus?
While no studies have specifically ruled
out the possibility of teratogenic effects, there are no
biomedical or scientific data to suggest that there would be
an increased risk of birth defects if Plan B fails or if a
woman who is already pregnant takes Plan B. Studies
involving women who have inadvertently taken combined oral
contraceptives containing levonorgestrel during early
pregnancy suggest that these drugs do not have an adverse
effect on the fetus.9
Is repeated use of Plan B harmful to women?
Given its potential to prevent unintended
pregnancy and lack of serious medical risks, Plan B can be
provided as frequently as needed. However, Plan B is not
recommended for routine use as a contraceptive among
sexually active women. Clients should be advised that the
failure rate of Plan B is calculated for a single use. If
Plan B is used on more than one occasion, the cumulative
failure rate will be higher.
How is Plan B provided?
Plan B can be provided through advance
prescription, prescription by telephone, walk-in
prescription, or an office visit. Neither a pelvic
examination nor a pregnancy test is required before
treatment. In planning for emergency contraceptive services,
it is important to keep in mind that the sooner Plan B is
taken after unprotected intercourse, the more effective it
is.6 Barriers to immediate access should be minimized.
Where
can I get more information?
For more information on Plan B, contact
Womens Capital Corporation, Post Office Box 5026, Bellevue,
Washington 98009. Phone: 800-330-1271.
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