Manufacturers of Norlevo, an emergency contraceptive sold in Europe, have decided to place a warning label on their product for women over a certain weight limit.
The pill is meant to prevent pregnancy if taken within the first few days after unprotected sex, but recent studies have found the product to be ineffective if consumed by a woman over 176 pounds.
“The effect of a women’s weight on levonorgestrel efficacy was first identified in 2011 during the development of an alternative emergency contraceptive product in the context of a clinical trial,” said a statement sent to the AFRO on behalf of HRA Pharma CEO Erin Gainer.
Gainer said that further tests were completed in 2012, and a decision to approach regulatory authorities was made in early 2013.
“By sharing the data in this manner it demonstrates a clear obligation by the company to be transparent with the healthcare community and provide regulators with the most up to date information to inform women.”
Norlevo contains the same active ingredient, levonorgestrel, as the Plan B emergency contraceptive pill approved for women in the United States.
"In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg (165 lbs) or more and levonorgestrel was not effective in women who weighed more than 80 kg (176 lbs),” reads the new labeling for Norlevo.
Though it is not marketed to American women, the decision to change the Norlevo label has raised questions about Plan B, which is marketed by Teva Pharmaceuticals in the United States.
“The FDA is currently reviewing the available and related scientific information on this issue, including the publication upon which the Norlevo labeling change was based,” said Erica V. Jefferson, deputy director of media affairs for the Food and Drug Administration. “The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted.”
“The original approval of Plan B for use in the U.S. did not include an assessment specific to weight. Norlevo is not approved under this brand name in the U.S.”
Denise Bradley, vice president of corporate communications for Teva Pharmaceuticals gave little indication that a label change for Plan B was coming in the near future.
“The data submitted in Europe to support the label change on Norlevo is HRA Pharma’s proprietary information, and as such, we have not had the opportunity to review it and cannot provide comment on that data at this time,” she said. “It is Teva’s policy not to comment on conversations with FDA. We have no further comment at this time.”
Women who are concerned about the efficacy of the pill, due to weight, are encouraged to speak with their doctors about long-term contraceptive methods, such as intrauterine devices (IUDs), daily oral contraceptives, diaphragms, female condoms, cervical caps or spermicide. Abstinence has also produced great results.
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