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:
- Call the toll free number 1-800-330-1271
- Visit their website www.go2planB.com
If you want more information about Plan B from FDA: