ROCKVILLE, Md., May 23 -- The FDA has approved the first continuous use oral contraceptive for prevention of pregnancy -- a pill that will eliminate a woman's monthly menstrual cycle.
The new oral contraception willl be marketed in 28-day pill packs under the brand name Lybrel. Developed by Wyeth, Lybrel contains 90 mcg of levonorgestrel(Drug information on levonorgestrel) and 20 mcg of estrogen.
Unlike other oral contraceptive regimens that include four to seven placebo or off-pill days in order to stimulate a menstrual cycle, the new pill continuously suppresses the production of hormones so that women would not have a scheduled menstrual period.
The FDA said, however, that women who use Lybrel are likely to have unplanned, breakthrough, unscheduled bleeding, or spotting.
At an FDA briefing Scott Monroe, M.D., of the agency's Center for Drug Evaluation and Research said about half the women in clinical trials, which included more that 2,400 women ages 18 to 49, stopped taking the drug because of unscheduled bleeding or spotting.
Of the remaining women who completed the trials, only 30%- to 35% had no bleeding or spotting. Bleeding and spotting occurred an average of four to five days per 28-day cycle, which is the same as for women on traditional birth control pills and even for women who don't take birth control pills at all.