Articles

Lybrel: The New No Period Birth Control

By Tiffany Spudich, R.Ph., Pharm. D.

The Food and Drug Administration (FDA) has approved Lybrel, the first continuous use drug product for prevention of pregnancy. Lybrel, a name meant to evoke "liberty," comes in a 28 day-pill pack with low-dose combination tablets that contain 90 micrograms of a progestin, levonorgestrel, and 20 micrograms of an estrogen, ethinyl estradiol, which are active ingredients available in other approved oral contraceptives. Continuous contraception works the same way as the 21 days on-seven days off cycle. It stops the body's monthly preparation for pregnancy by lowering the production of hormones that make pregnancy possible.
Lybrel is the fourth new oral contraceptive that doesn't follow the standard schedule of 21 daily active pills, followed by seven sugar pills - a design meant to mimic a woman's monthly cycle. Among the others, Yaz and Loestrin 24 shorten monthly periods to three days or less and Seasonique, an updated version of Seasonale, reduces them to four times a year. 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 occurrence of unscheduled bleeding decreases over time in most women who continue to take Lybrel for a full year. In the primary clinical study, 59 percent of the women who took Lybrel for one year had no bleeding or spotting during the last month of the study. However, 18 percent of women dropped out of studies because of spotting and breakthrough bleeding, according to Wyeth.
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. The effectiveness of the continuous oral contraceptive was reported to be similar to that of a traditional 21-day regimen and demonstrated a good safety profile. Health care professionals and patients are advised that when considering the use of Lybrel, the convenience of having no scheduled menstruation should be weighed against the inconvenience of unscheduled bleeding or spotting. Still, some women raise concerns about whether blocking periods is safe or natural. Baltimore health psychologist Paula S. Derry wrote in an opinion piece in the British Medical Journal that "menstrual suppression itself is unnatural," and that there's not enough data to determine if it is safe long-term."
Sheldon J. Segal, a scientist at the nonprofit research group Population Council, wrote back that a British study found no harm in taking pills with much higher hormone levels than today's products for up to 10 years.
"Nothing has come up to indicate any unexpected side effects," said Segal, who co-authored the book "Is Menstruation Obsolete?" However, that the long-term safety of continuous contraception remains unknown.
Eliminating periods with continuous oral contraceptives has been shown to be an effective treatment for many reproductive-related health problems, including endometriosis, as well as possibly reducing the symptoms of premenstrual syndrome. Most doctors say there's no medical reason women need monthly bleeding and that it triggers health problems from anemia to epilepsy in many women. They note women have been tinkering with nature since the advent of birth control pills and now endure as many as 450 periods, compared with 50 or so in the days when women spent most of their fertile years pregnant or breast-feeding.
Like other available oral contraceptives, Lybrel is effective for prevention of pregnancy when used as directed. 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. The labeling also carries a warning that cigarette smoking increases the risk of serious cardiovascular side effects from the use of combination estrogen and progestin-containing contraceptives. Birth control pills do not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Because Lybrel users will eliminate their regular periods, it may be difficult for women to recognize if they have become pregnant. It is recommended that a woman taking Lybrel who suspects she may be pregnant should have a pregnancy test or contact her physician. Women should also discuss contraceptive use, and the precautions and warnings for use of the drug product, with their doctors or other health care professional.

Sources:
www.drugs.com
www.webmd.com
www.lybrel.com
www.ap.org