The Medical Letter on Drugs and Therapeutics
In Brief: Plan B OTC
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Med Lett Drugs Ther. 2006 Sep 11;48(1243):75
 Select a term to see related articles  2006   antivirals   Contraceptives   emergency contraceptives   In brief   issue 1243   Plan B   Plan B OTC   September 11   volume 48 

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.

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