Studies have always shown that hormone-based birth control pills and patches can be less effective in heavier women, but a European manufacturer of the emergency contraceptive pill, Norlevo, will now put labels on its product informing women that their pill is “not effective” for women over 176 pounds and doesn’t work as well in women who weigh 165 pounds or more.
According to Mother Jones, which first reported the expected change Monday. HRA Pharma plans to update the package inserts on their pills, which are available in Europe, Australia, India and Canada, in 2014.
This lack of effectiveness has raised concern in many in the US because Norlevo contains levonorgestrel, the same ingredient found in Plan B One-Step. The FDA is now investigating whether or not a similar label is needed in the U.S because the original approval of the drug did not include a weight warning.
“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 Jefferson, deputy director for the FDA office of media affairs. “The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted.”
Teva Pharmaceuticals, the maker of Plan B, questioned the “bioequivalence” of the U.S. morning-after pills and Norlevo.
“We do not comment on our conversations with FDA,” said Denise Bradley, vice president of corporate Communications – Americas at Teva. “Also, we cannot comment on the nature of the bioequivalence of Norlevo to Plan B One Step® since Norlevo is not approved in the United States. The product does contain the same active ingredient, 1.5 mg of levonorgestrel.”
In an interview with NBC, Dr. Carolyn Westhoff said she doesn’t want to see women become overly alarmed by the study. “This is just a single result and we don’t have any way to replicate it,” said Westhoff, a professor of obstetrics and gynecology at Columbia University Medical Center.