The FDA 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 (e.g., condom). 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.
On June 10, 2013, the agency notified a United States District Court judge in New York of its intent to comply with the court’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. The agency has fulfilled its commitment to the court by promptly completing its review and approval of the supplemental application.
“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 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. It is important that young women who are sexually active see a health care provider for routine checkups. The health care provider should counsel the patient about, and test them 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.
See the FDA Announcement
See also Medical Law Perspectives, February 2012 Report: The New Oral Contraceptives: Stroke and Other Adverse Event Liability
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication