The FDA announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential.
This action complies with the April 5 order of the United States District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter product without age or point-of-sale restrictions.
After initial reports that it would appeal the decision and seek to restrict availability of the product for girls younger than 15, the Obama administration — which includes the FDA — has chosen to abide by the court ruling.
Plan B One-Step is an emergency contraceptive intended to reduce the chance of pregnancy following unprotected sexual intercourse or a known or suspected contraceptive failure. The single-dose pill (1.5 mg tablet) is described as effective at decreasing the chance of pregnancy, and should be taken as soon as possible within three days after unprotected sex.
On June 10, the FDA notified a federal judge in New York of its intent to comply with the courts order. Teva Womens Health, the manufacturer of Plan B One-Step, subsequently submitted a supplemental application seeking approval of the one-pill product to be made available without any restrictions. The FDA has completed its review and approval of the supplemental application.
Plan B One-Step was approved in July 2009 for use without a prescription for women 17 and older and as a prescription-only option for women younger than 17. In April, the FDA approved the product for nonprescription use for women as young as 15. With this week’s approval, the product is available without a prescription for use by all women of reproductive potential.
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.
Plan B One-Step will not stop a pregnancy when a woman already is pregnant, and there is no medical evidence that the product will harm a developing fetus, according to the FDA.
The product will not protect a woman from HIV/AIDS or other sexually transmitted diseases. The FDA stated that it is important for young women who are sexually active to see a healthcare provider for routine checkups. The provider should counsel the patient about and test her for sexually transmitted diseases, discuss effective methods of routine birth control and answer any other questions the patient may have.
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.