Content Update for Chapter 10, "Prevention of Pregnancy and Sexually Transmitted Infections"

FDA Approval of Dual-Status Plan B

The following information updates and supplements text in Chapter 10, "Prevention of Pregnancy and Sexually Transmitted Infections," in the Handbook of Nonprescription Drugs, 15th Edition.

Plan B

Plan B, a dedicated emergency contraceptive pill (ECP), was approved by the Food and Drug Administration (FDA) for nonprescription use in August 2006. Nationwide nonprescription sale of Plan B is restricted to women ages 18 and older. Women ages 17 and younger still need a prescription to obtain the product.¹ Prior to this approval, some states had dispensed ECPs through collaborative practice agreements with physicians; California state law had allowed pharmacists to provide emergency contraception to women without the women visiting their provider first.

Prescription and nonprescription versions of Plan B are distributed in the same package, with the primary display panel bearing the notice “Rx only for age 17 and under.” The dual-status version of Plan B was launched at the end of 2006 under the Convenient Access, Responsible Education (CARE) program. The primary elements of the FDA-approved CARE plan are as follows¹:

• Product must be stocked behind the pharmacy counter, and women must provide proof of age or a prescription to purchase the product.
• Manufacturer will provide labeling and education, including a toll-free number (1-800-330-1271) and Web site (www.go2planB.com), for consumers and health care professionals about the appropriate use of both versions of the agent.
• Product will be distributed through only licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed health care practitioners.
• Manufacturer will monitor the effectiveness of the age restriction, and the safe distribution of the nonprescription and prescription versions of the agent to women of the appropriate ages.

Mechanism of Action The exact mechanism of action of Plan B and other ECPs is unknown, but is believed to result primarily from the suppression of ovulation.² Other possible mechanisms of action include interfering with fertilization, inhibiting transport of the fertilized egg to the uterus, or inhibiting implantation of the fertilized egg in the endometrium.

Indications A package of Plan B contains two tablets, with each tablet containing 0.75 mg of levonorgestrel. Plan B is FDA approved to reduce the chance of pregnancy after unprotected sex (if a contraceptive method failed or was not used).³

Dosage and Administration Guidelines The Plan B package labeling instructs users to take the first tablet as soon as possible but no later than 72 hours (3 days) after unprotected sex, and to take the second tablet 12 hours after the first tablet.^3,4 However, Plan B is often given as a single dose of two pills with equal effectiveness.^5,6 Several studies have shown that ECPs are still effective if given within 5 days of unprotected intercourse.^6,7 Therefore, women should be counseled that Plan B is still effective when taken up to 120 hours after unprotected intercourse. Patients presenting between 5 to 7 days after unprotected intercourse should be referred to a physician for possible IUD insertion.

Safety Considerations Package labeling for Plan B lists the most commonly reported adverse effects of nausea and vomiting,^3,4 along with tiredness, menstrual changes, diarrhea, breast pain, stomach pain, dizziness, and headache. The only warning pertains to women who have experienced allergic reactions to levonorgestrel.³

Nausea has been reported to occur in about 50% of women using combination (estrogen and progesterone) ECPs and 25% of women using progesterone-only ECPs. Vomiting occurs in about 25% and 5% of combination and progesterone-only ECP users, respectively. Headaches, breast tenderness, and dizziness have also been reported. Plan B has been found to be more effective and better tolerated than combination pills. Patients may choose to take an antiemetic before each dose of Plan B or other ECPs to minimize nausea and vomiting. Table 10-13 on page 192 of the book provides other patient counseling information on ECPs.

References

1. US Food and Drug Administration. FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older: Prescription Remains Required for Those 17 and Under [news release]. August 24, 2006. Available at: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01436.html. Accessed June 25, 2007.
2. Croxatto HB, Brache V, Pavez M, et al. Pituitary-ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation. Contraception. 2004;70:442-50.
3. US Food and Drug Administration, Center for Drug Evaluation and Research. Plan B (0.75mg levonorgestrel) Tablets Information. Available at: http://www.fda.gov/cder/drug/infopage/planB/default.htm. Accessed June 25, 2007.
4. Stewart F, Trussell J, Van Look PFA. Emergency contraception. In: Hatcher RA, Trussell J, Stewart F, et al., eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media; 2004:279-303.
5. von Hertzen H, Piaggio G, Ding J. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomized trial. Lancet. 2002;360:1803-10.
6. Ellertson C, Webb A, Blanchard K, et al. Modifying the Yuzpe regimen of emergency contraception: a multicenter, randomized controlled trial. Obstet Gynecol. 2003;101:1160-7.
7. Rodrigues I, Grou F, Joly J. Effectiveness of emergency contraceptive pills between 72 and 120 hours after unprotected sexual intercourse. Am J Obstet Gynecol. 2001;184:531-7.