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No-Period Birth Control Pill Wins FDA Approval

The Food and Drug Administration (FDA) announced yesterday that Lybrel, the first low-dose oral contraceptive that eliminates monthly menstruation, is now approved for use in the US. Taken daily, Lybrel continuously delivers lower doses of the synthetic hormones found in traditional birth control pills, which are usually taken for 21 days followed by seven days of placebo pills. According to Wyeth Pharmaceuticals, the company that manufactures Lybrel, the regimen is just as effective as other FDA-approved oral contraceptives.

Many women’s health advocates welcome the FDA’s approval of a new option for women. “This pill is safe and effective,” said Feminist Majority Foundation Medical Director Dr. Beth Jordan. “In fact, many doctors have prescribed this regimen to patients — and have used it themselves — for decades. Now we have a dedicated product with years of safety data behind it.”

Based on clinical research, Wyeth found that 59 percent of women taking Lybrel stopped bleeding after six months. Eighteen percent of participants, however, dropped out of the clinical trials due to bleeding and spotting. Wyeth also found that interest in the pill depended on a woman’s personal approach to monthly periods. Fifty percent of women surveyed by Wyeth said they welcomed their periods as an indicator that they were not pregnant, while 25 percent said they saw their periods as a “natural part of womanhood,” according to Kaiser Daily Women’s Health Policy Report. In all, about two-thirds of women surveyed were interested in eliminating monthly periods.

Said Dr. Beth Jordan, “While this drug isn’t for everyone, it is a great option for women, either for health reasons or lifestyle concerns.”

Sources:

Kaiser Daily Women's Health Policy Report 5/22/07; Washington Post 5/23/07; LA Times 5/23/07; FDA 5/22/07; Wyeth release 5/22/07; AP 5/22/07