More information about Lybrel

Staff Writer
Contributor
Posted by Staff WriterMay 29, 2007 8:11 AM

In the news this past week, you may have heard about a new birth control pill called Lybrel, which frees women from the nuisance of having a menstrual period.

Lybrel was approved by the FDA and should be in pharmacies sometime this summer. The new drug is a low-dose version of the traditional birth control pill, and it contains 90 micrograms levonorgestrel and 20 micrograms ethinyl estradiol. It comes in 28-day pill packs with all pills containing hormones. Traditional pill packs also contain 28 pills, but the last 7 are placebos that do not contain any hormones, so the patient does have her period during those 7 days.

Lybrel use has raised questions and concerns among consumers and physicians alike. One of these issues include the increased difficulty in identifying pregnancy while taking the drug, since no menstrual periods occur. This could pose an extreme danger to a fetus in a woman taking Lybrel. Other issues that have come to the table include whether it is natural for a woman in her childbearing years not to have periods, the long-term effects of taking Lybrel, and more.

An online article at inrich.com offers more information on Lybrel:


Studies leading to approval: Two one-year clinical studies, enrolling more than 2,400 women, ages 18 to 49. Primary measure of effectiveness focused on pregnancy prevention. After about a year on the regimen, close to 60 percent of about 800 women who provided bleeding data reported having no periods. During the final cycle of Lybrel (pill pack 13 in the study), 31 percent of subjects experienced four or more days of bleeding or spotting a cycle and 20 percent experienced seven or more days of bleeding and/or spotting. Most women had some breakthrough bleeding. Postmarketing research will study incidents of blood clots in women taking Lybrel compared with women taking other oral contraceptives.


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