PhotoPlan B One-Step (levonorgestrel) is now available as a nonprescription product for all women of child-bearing potential.

The approval by the U.S. Food and Drug Administration (FDA) complies with the April 5, 2013, order of a federal court in New York to make levonorgestrel-containing emergency contraceptives available without age or point-of-sale restrictions.

Plan B One-Step, according to the FDA, is intended to reduce the chance of pregnancy following unprotected sexual intercourse or a known or suspected contraceptive failure (e.g., condom). The single-dose pill (1.5 mg tablet) was found to be effective in decreasing the chance of pregnancy and is meant to be taken as soon as possible within three days after unprotected sex.

“Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Plan B One-Step was first approved  in July 2009 for use without a prescription for women age 17 and older and as a prescription-only option for women younger than age 17. In April 2013, the product was approved. With this latest approval, the product is now available without a prescription for use by all women of reproductive potential.

What it does

The product contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to these contraceptive pills by stopping ovulation and therefore preventing pregnancy.

Plan B One-Step will not stop a pregnancy when a woman is already pregnant and there is no medical evidence that the product will harm a developing fetus.

Some women taking Plan B One-Step have reported experiencing the following side effects: nausea, vomiting, stomach pain, headache, dizziness and breast tenderness. These are similar to the side effects of regular prescription-only birth control pills.


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