Weight Of Emergency Contraceptive Data Does Not Support Label Change

 
• By Malcolm Spicer

Data are "conflicting and too limited to make a definitive conclusion," FDA says after reviewing scientific data concerning effectiveness of Plan B One Step and other 1.5mg levonorgestrel emergency contraceptives in women weighing more than 165 pounds.

FDA determined available scientific data do not support requiring label warnings on the effectiveness of levonorgestrel emergency contraceptives in women who weigh 165 pounds or more.

In separate documents addressed to health care providers and consumers posted recently to FDA's Postmarket Drug Safety Information website, the...

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