The US Food & Drug Administration is Looking into Whether Morning-After Emergency Contraceptive Pills Fail to Work in Women Over a Certain Weight
The FDA quickly addressed a recent report that European health regulators have ordered a label change on an emergency contraceptive product sold by French drugmaker HRA Pharma under the brand name Norlevo(levonorgestrel). The European authorities now require the drug’s labeling to address the potential that there is diminishing effectiveness of the pill depending upon the weight of the user. According to HRA, the emergency contraceptive begins to lose its effectivness for wormn who weigh more than 165 pounds and is completely ineffective for women who weigh more than 176 pounds. The label change will take effect in early 2014.
Norlevo is sold throughout Europe, Australia, parts of China and Africa and elsewhere in the world but this news also has major implications for women who take emergency contraceptive pills identical in chemical makeup and dosage to Norlevo in the United States. Some of the most popular emergency contraceptive pills sold over the counter in the United States—including the one-pill drugs Plan B One-Step, Next Choice One Dose, and My Way, and a number of generic two-pill emergency contraceptives—have a dosage and chemical makeup identical to the European drug. According to weight data from the Centers for Disease Control and Prevention (CDC) the average woman weight 166 pounds.
An FDA spokesperson indicated that the agency is “currently reviewing the available and related scientific information on this issue, including the publication upon which the Norlevo labeling change was based…The agency will determine what, if any, labeling changes to approved emergency contraceptives are warranted.”
We will continue to monitor and report developments in this arena. More information available, click here.