FDA gives green signal to Wyeth's "No-Period" birth control pill

The Food and Drug Administration (FDA) has approved Lybrel, the first continuous use oral contraceptive pill, manufactured by Wyeth Pharmaceuticals Inc.

Lybrel, containing a lower dose of synthetic hormones in a daily dose, has to be taken 365 days a year with no placebo pills. It is a low dose combination tablet that contains 90 micrograms of levonorgestrel, a progestrin and 20 micrograms ethinyl estradiol, an estrogen.

Similar to normal contraceptive pills, Lybrel stops the body's monthly preparation for pregnancy by lowering the production of hormones that make pregnancy possible.

Lybrel is designed to be taken without the placebo or pill-free time interval. Women who use Lybrel would not have a scheduled menstrual period, but will most likely have unplanned, breakthrough, unscheduled bleeding or spotting.

The safety and efficacy of Lybrel as a contraceptive method were supported by two one-year clinical studies, enrolling more than 2,400 women, ages 18 to 49. In clinical trials, the drug was 98 percent effective at preventing pregnancy when used as prescribed and after one year on the medication, 59 percent of subjects completely ceased any menstrual bleeding. The study also showed that 99 percent of 187 participants experienced either a return to menses or became pregnant within 90 days after stopping the study drug.

However, there has been a lot of discussion on the usage of this pill.

Jean Elson, a Sociology Professor at the University of Hampshire, has raised concern regarding the usage of this pill. According to her, it will perpetuate the stigma surrounding menstruation and is another attempt to medicalize women's natural biological life events.

Natalie de Vane, a representative for Lybrel manufacturer Wyeth pharmaceuticals, responded that the company does not believe that the treatment casts menstruation in a negative light. "From our research, we haven't heard that women felt that way. We heard that women are interested in not having their period. For some women, their period can be problematic. The idea behind bringing this to market was to offer a new option to women," she said.

According to Elson, taking hormones for a long time without release may not be in women’s best health interests. Also, women who use Lybrel will not be able to detect any health issued based on the changes in their monthly cycle. For example, a small percentage of women on low-dose hormone treatments experience unexpected pregnancy, and Elson fears that without a regular period, some women will not realize that they are carrying a child until later in their pregnancies.

According to Paula Amato, a gynecologist and professor at Baylor College of Medicine in Houston, there’s no real medical need to have withdrawal bleed at all. He pointed towards the advantages of eliminating the withdrawal bleed such as reducing pain, headaches, moodiness and bloating and also improved productivity at work.

Regarding the safety concerns, the risks of using Lybrel are similar to the risks of other conventional oral contraceptives and include an increased risk of blood clots, heart attacks, and strokes.

Elson accepts that the drug may help a number of women with extraordinary menstrual problems, such as endometriosis and fibroid tumors, but fears that the treatment will become popular among young, healthy women who may not know about potential side-effects like breakthrough bleeding.

Thus, using Lybrel is a choice, but it's a choice that women should be informed about. They should know as much as possible.