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First Contraceptive for Continuous Use

FDA approved the first continuous-use drug product for the prevention of pregnancy, on May 22, 2007. The new contraceptive, Lybrel, is manufactured by Wyeth of Philadelphia, Pa.

Active ingredients:

Lybrel 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. These are active ingredients available in other approved oral contraceptives.

How Lybrel works:

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. Other contraceptive pill regimens have placebo or pill-free intervals lasting 4 to 7 days that stimulate a menstrual cycle. 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.

Unscheduled bleeding or spotting:

When considering the use of Lybrel, health professionals and patients should weigh the convenience of having no scheduled menstruation against the inconvenience of unscheduled bleeding or spotting. Unscheduled bleeding decreases over time in most women who continue to take Lybrel for a full year.

Safety and effectiveness:

Like other available oral contraceptives, Lybrel is effective for pregnancy prevention when used as directed. The safety and effectiveness of Lybrel were supported by 2 one-year clinical studies, enrolling more than 2,400 women, ages 18 to 49. The risks of using Lybrel are similar to the risks of other conventional oral contraceptives.

• There is an increased risk of blood clots, heart attacks, and strokes.
• Cigarette smoking increases the risk of serious cardiovascular side effects from the use of combination estrogen and progestin-containing contraceptives.
• Because people who use Lybrel won't have regular periods, it may be difficult for women to recognize if they have become pregnant. Women should take a pregnancy test if they believe they may be pregnant.
• Birth control pills do not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Women should discuss contraceptive use, and the precautions and warnings for use of the drug product, with their doctor or other health care professional.

Date Posted: May 29, 2007

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