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Plan B: Questions and Answers
August 24, 2006, updated December 14, 2006
1. What is FDA announcing today?
FDA is announcing the approval of the emergency contraceptive
drug Plan B as an over-the-counter (OTC) option for women aged 18
and older. A prescription-only form of Plan B will remain available
for young women aged 17 and younger.
2. What is emergency contraception?
Emergency contraception is a method of preventing pregnancy after
a contraceptive fails or after unprotected sex. It is not for
routine use. These pills contain higher levels of a hormone found in
daily oral hormonal contraceptives. FDA has approved two products
for this prescription use – Preven (approved in 1998 but is no
longer being marketed) and Plan B (approved in 1999).
3. What is Plan B?
Plan B is emergency contraception, a backup method to birth
control. It is in the form of two levonorgestrel pills (0.75 mg in
each pill) that are taken by mouth after a contraceptive fails or
after unprotected sex. Levonorgestrel is a synthetic hormone used in
birth control pills for over 35 years. Plan B can reduce the chances
of a woman becoming pregnant when taken as directed if she has had
unprotected sex. Prior to this action, Plan B was available only by
prescription.
4. How does Plan B work?
Plan B works like a birth control pill to prevent pregnancy
mainly by stopping the release of
an egg from the ovary. It is possible that Plan B may also work by
preventing fertilization of an egg (the uniting of sperm with the
egg) or by preventing attachment (implantation) to the uterus
(womb), which usually occurs beginning 7 days after release of an
egg from the ovary. Plan B will not do anything to a fertilized egg
already attached to the uterus. The pregnancy will continue.
5. Are there any side effects?
According to reports from clinical trials, some women will
experience non-serious side effects, such as nausea, stomach pain,
headache, dizziness, or breast tenderness. These are similar to the
side effects of regular birth control pills.
6. How should Plan B be administered?
Plan B should be taken orally as soon as possible and within 72
hours of unprotected sex. The second tablet should be taken 12 hours
after the first tablet. Data shows Plan B is more effective the
sooner treatment is started following unprotected sex.
7a. How can I purchase over-the-counter Plan B?
Plan B will only be sold in pharmacies/stores staffed by a
licensed pharmacist. In order to purchase Plan B over-the-counter,
personal identification showing proof of age (18) is required. Plan
B will be available behind the counter at the pharmacy in order to
manage both prescription (17 years and under) and OTC (18 years and
over) dispensing. This means Plan B will not be sold at gas stations
or convenience stores, where other OTC products are routinely
available.
7b. Can men purchase Plan B? (added 12/14/2006)
Yes. Plan B OTC is approved to allow OTC availability of Plan B for consumers 18 years and older. Plan B remains available by prescription only for women 17 years and younger.
8. What should I do if I have questions about Plan B?
If you have questions or need more information about Plan B from
the company you should:
If you want more information about Plan B from FDA:
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Date created: August 24, 2006; Last updated: December 14, 2006 |
