FDA to review efficacy issues in morning-after pill

Share this article:

HRA Pharma, a French drug manufacturer, says that its levonorgestrel-based emergency contraceptive, Norlevo,  loses efficacy in women who weigh over 165 pounds, and is ineffective in women who weigh over 176 pounds. The drugmaker requested permission to update its label from EU regulators.

FDA, responding to a query from Reuters on Monday, said they are "currently reviewing the available and related scientific information on this issue, including the publication upon which the Norlevo labeling change was based," and that "the agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted."

A spokeswomen for HRA Pharma told Mother Jones that upping the dosage does not solve the problem.

Plan B, sold by Teva Pharmaceuticals, and generic versions thereof, are also levonorgestrel-based emergency contraceptives.

Share this article:
You must be a registered member of MMM to post a comment.
 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.