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US Regulators Consider Whether Label Changes Needed on Morning-After Pill

Updated: 11/26/2013 1:26 PM
Created: 11/26/2013 11:15 AM WDIO.com

PARIS (AP) - Some doctors are saying heavy women shouldn't assume that emergency contraception won't work for them -- despite Tuesday's announcement from a French drug company.

The company says its morning-after pill doesn't work when it's taken by women who weigh more than 176 pounds. The company (HRA Pharma) is planning to change its labels to warn patients.

The drug -- Norlevo -- isn't sold in the United States. But another drug with the same active ingredient (levonorgestrel) is widely available. The French company says its morning-after pill contains the same amount of that ingredient that is found in Plan B One-Step, manufactured in the U.S.

In Washington, a spokeswoman for the Food and Drug Administration says the agency is looking at the issue, and will determine if any labeling changes to emergency contraceptives are necessary.

A spokeswoman for Britain's Faculty of Sexual and Reproductive Healthcare says in overweight and obese women, the drug may get absorbed into their fat more quickly, and doesn't have enough time to work in their bodies.

(Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.)

 

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