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Plan BInformation about Plan B
Plan B - 11 Questions,
11 Answers
What you need to know
about Plan B, the emergency contraceptive
WebMD - August 24, 2006
Here are 11 questions and answers on
the emergency contraceptive Plan B and its FDA approval for
over-the-counter sales to women aged 18 and older.
1. What is Plan B?
Plan B is an emergency contraceptive
pill taken by mouth after unprotected sex. It is used to prevent
pregnancy. It is not for routine contraceptive use and does not
prevent against sexually transmitted diseases, including HIV.
2. How is Plan B taken?
Plan B should be taken within 72
hours of unprotected intercourse. When taken within 72 hours, it
decreases the chance of getting pregnant by 89% -- from 8%
without Plan B to 1% with Plan B.
It's even more effective when taken
within 24 hours. Effectiveness decreases the longer a woman
waits to take it.
3. Who may buy Plan B over
the counter?
Women aged 18 and older. Although
available over the counter, Plan B will be kept behind the
pharmacy counter. Women will need to ask the pharmacy staff for
Plan B and may need to show proof of age.
4. What about younger women?
Women aged 17 and younger can still
get Plan B by prescription.
5. Why is there an age
restriction for Plan B's over-the-counter sales?
The FDA says they wanted to treat it
like other prescription products, such as nicotine- replacement
products, that require that age. They thought for this program
to work, age 18 made sense.
6. When will Plan B become
available over the counter?
Barr Pharmaceuticals, Plan B's
maker, plans to introduce over-the-counter sales of Plan B to
women aged 18 and older by the end of 2006.
7. What is Plan B's active
ingredient?
Each Plan B pill contains 0.75
milligrams of levonorgestrel, a synthetic version of the hormone
progestin.
Levonorgestrel has been used in
birth control pills for over 35 years. Plan B contains a higher
dose and is taken as two separate doses 12 hours apart.
8. Is Plan B a new drug?
No. It's been available by
prescription to all women since 1999.
Plan B has never before been sold
over the counter in the U.S.
9. How does Plan B work?
Plan B works like other birth
control pills to prevent pregnancy. Plan B acts primarily by
stopping the release of an egg from the ovary. It may prevent a
sperm from fertilizing the egg.
If fertilization does occur, Plan B
may prevent a fertilized egg from attaching to the womb. If a
fertilized egg is implanted prior to taking Plan B, Plan B will
not work and pregnancy proceeds normally.
10. Does Plan B have any
side effects?
Like any medication, Plan B does
have side effects. The most common side effect is nausea, which
occurs in about a quarter of women after taking Plan B. Other
side effects include abdominal pain, fatigue, headache, and
heavy menstrual bleeding.
11. Is Plan B the same as
RU-486?
No. RU-486, sold as Mifeprex, is a
prescription drug for medical abortion. Mifeprex is used after a
woman is already pregnant. Plan B is an emergency contraceptive.
It is used to prevent pregnancy. While some people do feel that
pregnancy begins at the time of conception, many doctors and the
FDA do not describe Plan B as an abortion pill but as emergency
contraception.
SOURCES: News release, Barr
Pharmaceuticals. FDA: "FDA's Decisions Regarding Plan B:
Questions and Answers," May 7, 2004. Steven Galson, MD, MPH,
director, FDA's Center for Drug Evaluation and Research.
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