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FDA Approves No-Period Contraceptive

By Matthew McKinney, published Jun 26, 2007
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Recently, the FDA has approved a drug that will alter a woman's menstrual cycle, in effect stopping it altogether for an indefinite period of time. According to the FDA, however, most women will more than likely still have small amounts of bleeding or spotting. Dr. Daniel Shames, deputy director of the Office of Drug Evaluation III at the FDA's Center for Drug Evaluation and Research, still thinks that women should deeply consider the side effects and possibilities of the pill before taking it. He states, "I think each woman and her health care provider will have to look at the data, which we have explicitly defined in our labeling, and decide if this form of contraception is appropriate for her."

The new pill, called Lybrel, is engineered by Wyeth Pharmaceuticals. It contains the same basic chemical as most of the other oral contraceptives. The main difference is that the pill gets rid of the four to seven day placebo method of medication by continuously applying birth control medication to the body without any time for menstruation. Although this whole idea may sound unsafe, the FDA approved the drug based on two clinical trials that were performed that each lasted a year, including 2,400 women between the ages of 18 and 49. Both trials found the drug to be completely safe as long as it is taken as directed.

However, not every woman remained in the study. In fact, by the end of the study, only half of the women remained, mainly because those that dropped out experienced minor bleeding and spotting. Only a total of about 35% of the women in the study experienced no bleeding or spotting at all.

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Another great article that I can benefit from.

Posted on 06/28/2007 at 9:06:00 AM

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