Plan B: Questions and Answers

August 24, 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.

Plan B - the morning after 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 - Emergency Contraceptive?

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 other oral birth control pills to prevent pregnancy. Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization).

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.

7. 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.

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