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  5. Plan B: Consumer Questions and Answers
  1. Postmarket Drug Safety Information for Patients and Providers

Plan B: Consumer Questions and Answers

Q1. What has the FDA concluded about the effectiveness of levonorgestrel-containing emergency contraceptives in women who weigh more than 165 pounds or have a Body Mass Index (BMI) above 25 kg/m2?

A: The FDA has completed a review of available scientific data concerning effectiveness of levonorgestrel (LNG) emergency contraceptives (ECs) in women who weigh more than 165 pounds or have a BMI of more than 25 kg/m2. Because these data are conflicting and too limited to make a definitive conclusion, the FDA does not believe that a change in the labeling for LNG EC products is warranted at this time. There are no safety concerns that preclude use of LNG ECs in women generally, and the FDA continues to believe all women, regardless of how much they weigh, can use these products to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.

The most important factor affecting how well emergency contraception works is how quickly it is taken after unprotected sex or contraceptive failure. Therefore, the FDA recommends that all women using LNG emergency contraceptives follow the product directions exactly and take the product as soon as possible within 72 hours after unprotected sex or contraceptive failure.

The FDA recommends that women talk to their health care provider about emergency contraception in advance of needing it and understand the importance of using these products as intended and as labeled.

Consumers and health care professionals are encouraged to report adverse reactions from the use of LNG ECs to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.

Q2. What emergency contraceptive products contain levonorgestrel?

  • Plan B and Plan B One-Step
  • Take Action
  • Next Choice and Next Choice One Dose
  • My Way
  • Levonorgestrel tablets (two 0.75 mg tablets)
  • After Pill
  • Fallback
  • Opcicon One-Step

 

Q3: Are there other options for emergency contraception?

A: The only FDA-approved emergency contraceptive in the United States that does not contain LNG is ella (ulipristal acetate) and is available by prescription. The FDA recommends that women speak with their health care professionals about emergency contraception in advance of needing it, and understand the importance of using these products as intended and as labeled.

Q4. How did the effectiveness of LNG emergency contraceptives come into question?

A: HRA Pharma, the French manufacturer of Norlevo, an emergency contraceptive containing LNG marketed in Europe, submitted data to European regulators, stating its product did not work for women who weigh more than 80 kg (176 lbs). In November 2013, regulators in France and certain other European countries agreed to labeling changes proposed by HRA Pharma, stating that Norlevo is less effective in women weighing 75 kg (165 lbs) or more and not effective in women weighing 80 kg (176 lbs) or more.

However, after this action in France, the European Medicines Agency (EMA) undertook a full review of the available data, and determined that the data were too limited and not robust enough to conclude with certainty that contraceptive effectiveness is reduced with increased body weight. Results of the applicable clinical studies were included in the product information of LNG ECs, but the statements on the impact of body weight in the product information for Norlevo were deleted.

The FDA also began an independent review of the relevant data. The agency has now completed review of available scientific data and has determined that these data are conflicting and too limited to make a definitive conclusion. The FDA does not believe that a change in the labeling for LNG EC products is warranted at this time. There are no safety concerns that preclude use of LNG ECs in women generally, and the FDA continues to believe that all women, regardless of how much they weigh, can use these products to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.