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

Plan B: Health care professional Questions and Answers

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

A: Current information about whether levonorgestrel (LNG) emergency contraceptives (ECs) work as well in women who weigh more than 165 pounds or have a BMI above 25 kg/m2 is conflicting and limited. 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.

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

Q2. What information did the FDA review to come to this determination?

A: The FDA reviewed the data submitted in the marketing applications used to support approval of Plan B and Plan B One-Step (levonorgestrel), and ella (ulipristal acetate). Additional analyses of data submitted in the ella marketing application were also published and the FDA reviewed these publications as well.

The original reviews of the data supporting approval of Plan B are available at:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-045_PlanB.cfm

The summary review of the data supporting approval of Plan B One-Step is available at:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021998s000_SumR.pdf

The summary review of the data supporting approval of ella (ulipristal acetate) is available at:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022474s000SumR.pdf

Q3. Are more data being gathered?

A: Because the currently available data are limited and conflicting, the FDA believes further research by the manufacturers of these products on the possible impact of weight or BMI on effectiveness should be a priority.

Q4: What levonorgestrel (LNG) emergency contraceptives (ECs) are approved in the U.S.?

A: The following products are FDA-approved as LNG emergency contraceptives:

  • 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
  • Opicion One-Step

Q5. What should health care professionals tell their patients?

A: The FDA recommends health care professionals talk to their patients about emergency contraception in advance of needing it, and emphasize 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.

Q6. How did the effectiveness of LNG emergency contraceptives come into question?

A: HRA Pharma, the French manufacturer of Norlevo (one of the LNG-containing EC products 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 for its LNG EC Norlevo, 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 all women, regardless of how much they weigh, can use these products to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.