FDA officially approves Plan B One-Step for all women

FDA 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.

“[This approval] demonstrates the possible finality to a longstanding and controversial debate about the accessibility of emergency contraceptive to women and the associated age parameters,” said Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “The gradual revisions that have occurred over time, from the age restriction of 17 years and older in July 2009 to 15 years and older in April 2013, to this most recent approval for the nonprescription purchase illustrates FDA’s willingness to allow women to have more control over their reproductive health, and make choices accordingly without being met with significant restrictions.”

Plan B One-Step emergency contraceptive is intended to reduce pregnancies from unprotected sexual intercourse or a known or suspected contraceptive failure (eg, condom). Plan B One-Step single-dose 1.5-mg tablet is effective in decreasing the chance of pregnancy and should be taken as soon as possible within 3 days after unprotected sex.

On June 10, 2013, FDA notified a U.S. District Court judge in New York of its intent to comply with the court’s April 5, 2013 order instructing the agency to make levonorgestrel-containing emergency contraceptives available as an OTC product without age or point-of-sale restrictions. To comply, 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. The agency has fulfilled its commitment to the court by promptly completing its review and approval of the supplemental application.

Plan B One-Step was first approved in July 2009 for use without a prescription for women 17 years and older and as a prescription-only option for women younger than 17. In April 2013, the product was approved for nonprescription use for women as young as 15. 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. 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. The product will not protect a woman from HIV/AIDS or other sexually transmitted diseases.

Side effects experienced by some women taking Plan B One-Step include nausea, vomiting, stomach pain, headache, dizziness, and breast tenderness. These are similar to the side effects of regular prescription-only birth control pills.