European regulator OKs use of 'morning-after' pill for all women

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A European company announced late 2013 that one of its emergency contraceptives stops working for women over 176 pounds.

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CC BY-ND WikiCommons
CC BY-ND WikiCommons

European drug maker HR Pharma announced in Nov. 2013 that its emergency contraceptive (EC) pill Norlevo, which shares the same active ingredient with the Plan B pill, loses its effectiveness for women over 165 pounds and becomes completely ineffective for women over 176 pounds.

The European Medicines Agency said July 24 that the EC pill Norlevo is still approved for use by all women. The regulator said there's not enough evidence to support the claim that the pill loses effectiveness for heavier women. The agency also said warnings of ineffectiveness on the pill's packaging should be removed.

HR Pharma's warning prompted the FDA to review whether U.S. drug manufacturers need to relabel their EC pills accordingly. When Plan B was first approved by the FDA, it did not include assessments for the patient's weight. Plan B is the only EC available to all women in the U.S. without a prescription.

The issue of reduced or lost effectiveness had been discovered accidentally in a separate study from 2011, which found that obese women were over three times more likely to get pregnant after using EC as women with normal BMIs.

"I don't know that the word is really out there enough yet, and that really concerns me, because this can cost women $50 a pop to take this medication, and then it doesn't work and then they're pregnant." Linda Prine, Reproductive Health Access Project medical director

Prine had said that makers of both Plan B and generic versions that also use levonorgestrel should be made to include labels to warn obese and overweight women of pregnancy risks.

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