The FDA has approved over-the-counter (OTC) sales of Plan B (Duramed), an emergency contraceptive package that contains two 0.75-mg tablets of levonorgestrel, to women ≥18 years old. Younger women still require a prescription. In one trial, two levonorgestrel 0.75-mg tablets taken 12 hours apart, the first within 72 hours after unprotected intercourse, decreased the pregnancy rate to 1%, compared to an expected rate of 8% (Task Force on Postovulatory Methods of Fertility Regulation, Lancet 1998; 352:428). How high doses of a progestin taken after coitus prevent pregnancy is unclear; they may interfere with ovulation, fertilization or implantation.
Nausea and vomiting can occur. The drug will not terminate an established pregnancy. No fetal malformations have been reported after unsuccessful use.
Plan B will not be available OTC until the end of the year, according to the manufacturer, and the OTC price is not yet available. The retail price for the prescription product varies from about $25 to $40. In order to enforce the age restriction, the drug will be kept behind the pharmacist’s counter, and a valid photo ID will be required.