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Morning-After Pill Fails to Work Properly Once Woman’s Weight Surpasses 165 Pounds

Filed November 27th, 2013 Laurie

U.S. health regulators said Monday they were looking into whether the Plan B emergency contraceptive pill loses its potency in women over 165 pounds.

The pills, sold in the U.S. under the brand name Plan B One-Step and various generics, and in Europe as Norlevo, are designed to prevent pregnancy in women after intercourse. Health regulators in Europe told HRA Pharma, Norlevo’s manufacturer, that it should revise the drug’s label to warn that the pills are less effective in women weighing over 165 pounds, and that the drug lose its potency entirely in women weighing more than 176 pounds, according to the Wall Street Journal (WSJ).

About a year ago, a study found that the pills started to lose their effectiveness as a woman’s weight increased, prompting HRA Pharma at that time to ask European health regulators about any potential need to add a warning to the label. Erin Gainer, chief executive of privately held HRA Pharma, told WSJ that all of the Norlevo packages should have revised labels sometime during the first quarter of 2014.

A U.S. Food and Drug Administration (FDA) spokesperson told WSJ 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 then determine what, if any, labeling changes to approved emergency contraceptives are warranted.”

Plan B uses a high dose of the female hormone progestin, which is also found in birth-control pills, to block an egg that would have been fertilized from becoming implanted in a woman’s uterus. In the U.S., the mean weight for Plan B users ages 20 and over is 166 pounds, according to a study by the U.S. Centers for Disease Control and Prevention (CDC), the WSJ reported.

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