FDA Approves Pill to Stop Period
Birth control drug halts menstruation, but breakthrough bleeding occurred in trials.
The Food and Drug Administration has approved a birth control pill designed to eliminate a woman's monthly period. The pill, called Lybrel uses a combination of low-dose synthetic hormones used in other oral contraceptives now on the market. But all of the 28 pills that come in a monthly pack will contain active ingredients, forgoing the placebo tablet that normally allow menstruation to begin.
In previous years, contraceptive makers have introduced a variety of products designed to minimize the frequency and duration of periods. Yaz, made by Bayer Health-Care Pharmaceuticals, and Loesstrin 24 Fe from Warner Chilcott, came on the market recently with the promise of shortening periods to four days or less. Seasonale and Seasonique, sister products from Barr Pharmaceuticals, limit periods to four times a year.
Lybrel, from Wyeth Pharmaceuticals takes the trend a step further by attempting to suppress periods altogether. "Why have a period at all?" said Dr Gerardo Bustillo, assistant chief of obstetrics and gynecology at Orange Coast Memorial Medical Center in Fountain Valley.
But Lybrel doesn't quite reach that goal, based on the results of two clinical trials involving 2,400 women ages 18-49. According to the FDA, the women experienced unscheduled breakthrough bleeding or spotting, though the incidence of such events decreased over time. In one study, 59% of women who took Lybrel for one year reported no bleeding during the last month. Many women stopped taking the pill after experiencing unscheduled bleeding.
Birth control pills contain synthetic versions of estrogen and progestin that prevent ovulation. Without such production of an egg, a pregnancy cannot occur.
The national Centers for Disease Control and Prevention estimate that 11.6 million American women use birth control pills, but it is unclear how many might prefer a product like Lybrel. "It is not for everybody," said Dr. Ricardo Azziz, chair of obstetrics and gynecology at Cedars-Sinai Medical Center in Los Angeles. "Some women like to have a period every month to reassure them that they are not pregnant. Some women may feel more "natural" by having that period."
Wyeth and other drug companies say their research indicates many women want a pill to stop their periods. But product sales have not lived up to the drug makers' expectations.
Los Angeles Times - May 23, 2007