FDA Clears Wyeth Contraceptive Pill By JENNIFER CORBETT DOOREN May 23, 2007; Page A4 WASHINGTON -- The Food and Drug Administration approved the first birth-control pill that is also designed to eliminate women's monthly periods. The pill, Wyeth's Lybrel, contains low-dose hormones and should be taken every day. Traditional birth-control pills contain 21 "active" pills with hormones and seven placebo pills. Women using traditional birth-control pills typically get a period a few days after taking the last active pill in a given month. Lybrel will come in a 28-day pill-pack. The pills contain 90 micrograms of a progestin, levonorgestrel, and 20 micrograms of an estrogen, ethinyl estradiol, which are also active ingredients in many other types of birth-control pills. Barr Pharmaceuticals Inc. markets two birth-control regimens that limits periods to four a year. All birth-control pills are designed to prevent pregnancy by stopping women from ovulating or releasing an egg. Other birth-control pills, such as Bayer AG unit Bayer Healthcare's Yaz, can shorten monthly periods. However, the FDA said many women using Lybrel will likely have unplanned, breakthrough bleeding or spotting, although such bleeding decreases over time. The FDA said one of the main studies of Lybrel showed 59% of the women who took Lybrel for one year had no bleeding or spotting during the last month of the study. Lybrel was studied in clinical trials involving more than 2,400 women ages 18 to 49. The FDA said 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. Daniel Shames, a deputy director in FDA's Center for Drug Evaluation and Research said it doesn't appear that eliminating women's monthly periods poses any significant safety issues, but said Wyeth will study Lybrel after it is on the market to see if any unexpected safety problems develop. Like other low-dose birth-control pills, women's chances of becoming pregnant rise if they miss pills. Wyeth, based in Madison, N.J., said Lybrel would be available starting in July. The company applied for FDA approval of Lybrel in 2005, but the approval had been delayed partly until the company resolved problems with a manufacturing plant in Guayama, Puerto Rico, where Lybrel is made. Earlier this month, Wyeth said the FDA notified the company the problems found by the agency at the Guayama plant had been corrected.