Emergency contraceptive (EC) drugs are again a source of controversy and news. Access to these drugs has recently expanded and more changes may come about as a result of litigation, so it is important to understand the facts and to follow any changes.
On April 30th of this year, the FDA approved the sale of Plan B One-Step EC for use without a prescription, by women who are 15 and older. Consumer access to EC has been increasing over recent years. Both men and women can purchase EC, and there are no limits to the frequency of purchase. In June 2009, the FDA provided approval for a generic prescription-only version of Plan B EC for women ages 17 and under. On April 5, 2013, a New York federal judge ordered the FDA to grant a 2001 citizen's petition that sought over-the-counter access to Plan B, for women of any age, and/or to make Plan B One-Step available with no age or point of sale restrictions. The application to market Plan B One-Step for women 15 and older was already pending prior to that ruling. The FDA stated that the April 30th approval for Plan B One-Step does not affect the prescription status of other drugs, nor is the approval intended to address the judge's ruling.
Prevention of unintentional pregnancies continues to be a critical topic, and in order to improve the situation, provider and patient awareness of EC drugs is necessary. Today, approximately 50% of pregnancies in the US are unintended. EC regimens can help reduce this percentage. Emergency contraceptive regimens include use of progestin-only pills, combination estrogen-progestin oral contraceptives, and copper intrauterine devices. Currently, three EC drugs are marketed in the US: Plan B One-Step, Plan B, and ella.
It is as important to be aware of the appropriate indications for EC. These drugs give a way to prevent pregnancy after unprotected intercourse, but patients should be informed that they do not protect against sexually transmitted diseases. Another important detail to emphasize is that EC drugs are not abortion pills. EC will not interrupt an established pregnancy. Patients should take EC as soon as possible after contraceptive failure or unprotected intercourse, in order for it to be effective at preventing pregnancy.
Plan B, available as a generic, uses two doses of levonorgestrel (0.75 mg in each tablet), that are taken 12 hours apart. Plan B One-Step is a single-dose pill (1.5 mg tablet) that is most effective if it is taken immediately or within 3 days after unprotected intercourse. Ella (ulipristal) is a prescription-only drug that prevents pregnancy when taken within 120 hours after unprotected intercourse. The success rates of EC drugs are high; if they are taken in the first 72 hours after intercourse, they are 82% effective at preventing pregnancy, and if taken between 72 to 120 hours, they are 62% effective. There are possible side effects with the drugs, but they are generally described as mild. Reported effects include nausea and vomiting, irregular vaginal bleeding, abdominal pain, breast tenderness, headache, dizziness, fatigue, and change in timing of the next menstrual period.
The PDR Network can be a useful resource for these and other drug types, offering alerts and specific product labeling. Keep current with information on products like levonorgestrel and ulipristal by using PDR.net, and by checking PDR BRIEF and/or searching in your EHR. Learn more about PDR in your EHR.
Salvatore Volpe, MD, FAAP, FACP, CHCQM
Chief Medical Officer
PDR Network
Resources
American College of Obstetricians and Gynecologists, District II. Latest Options in EC: A Toolkit for Health Care Providers & their Patients on Emergency Contraception. December 2009.
U.S. Food and Drug Administration. FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under. June 24, 2009. Online content. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm168870.htm. Accessed April 29, 2013.
U.S. Food and Drug Administration. FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older. Online content. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htm. Accessed May 1, 2013