US approves sale of morning-after pill for all ages

US authorities have approved over-the-counter sale of a morning-after pill for all women of child-bearing potential, lifting age limits on the emergency contraceptive.
The US Food and Drug Administration (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, 2013 order of the United States District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions.
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.

Plan B One-Step is a single-dose pill (1.5 mg tablet) that is effective in decreasing the chance of pregnancy and should be taken as soon as possible within three days after unprotected sex, FDA said in a statement.
On June 10, 2013, the agency notified the Court of its intent to comply with it's April 5, 2013 order instructing the FDA to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions.

To comply, the FDA asked Teva Women's Health, the manufacturer of Plan B One-Step, to submit a supplemental application seeking approval of the one-pill product to be made available without any restrictions.

"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, 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 aged 17 and older and as a prescription-only option for women younger than age 17.
With this approval, the product is now 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 and therefore preventing pregnancy.

According to FDA, some women taking Plan B One-Step have reported experiencing side effects such nausea, vomiting, stomach pain, headache, dizziness and breast tenderness, similar to the side effects of regular prescription-only birth control pills.