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Misleading ads.

The Food and Drug Administration recently warned Barr Research that one of its advertisements for the oral contraceptive Seasonale (levonorgestrel/ethinyl estradiol) was misleading consumers. "By omitting and minimizing the risks associated with Seasonale, the TV ad misleadingly suggests that Seasonale is safer than has been demonstrated by substantial evidence or substantial clinical experience," the FDA said in a letter. The ad fails to mention that patients using Seasonale may experience breakthrough bleeding or spotting for up to a year, according to the letter. In addition, the ad minimizes risk information through fast-paced scene changes, background music, and compelling visuals, according to the FDA. Barr intends to work with FDA to make the necessary change to the ad, according to company spokesman Carol A. Cox. "Seasonale is safe and effective oral contraception when used as directed, and we intend to continue to educate all consumers and health care providers about the product, its indications, risks, and side effects," she said.
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Title Annotation:POLICY & PRACTICE
Author:Schneider, Mary Ellen
Publication:OB GYN News
Date:Feb 1, 2005
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